Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis
NCT ID: NCT04344353
Last Updated: 2021-07-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
80 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-01-01
Study Completion Date
2021-01-01
Brief Summary
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This study evaluates and compares aortic calcium by computed tomography and histopathology in patients with aortic stenosis.
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Detailed Description
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1. Title
Analysis and comparative evaluation of aortic calcium by computed tomography and histopathology in patients with aortic stenosis.
2. Background.
Calcified aortic valve disease (CAVD) was initially considered to be a passive degeneration of the extracellular matrix (EM). Recent studies have shown that within the development of the damage mechanism there is complexity and it is an active (1) and degenerative process where genetic, environmental and epigenetic phases overlap and interact leading to hemodynamic changes in blood flow, endothelial dysfunction and metabolic disorders that lead to low-density lipoprotein cholesterol deposits in the ME where at the same time there is an underlying infiltration of macrophages, oxidative stress, and release of pro-inflammatory cytokines. (2) However, although there are several theories of damage, and some of them are attributed to a diversity of origin such as genetic, congenital, infectious, and degenerative. Finally, the dynamic and functional impact of the heart affects equally. It leads to organic deterioration when the AD reaches clinical and echocardiographic criteria of severity, and the only therapeutic option is the change or replacement of the aortic valve.
The participation of imaging methods such as computerized tomography about to the concerning the aortic valve through the measurement of the aortic calcium score (AVC-CT) as a method to determine the severity of aortic stenosis (AS) in those cases where echocardiographic measurements are conflicting, allows us to see the interest in defining this problem through different angles of investigation (7). In AD, progressive calcification is the trigger factor that also predominantly leads to aortic valve obstruction. (3) Currently, such calcification can be easily quantified using the same acquisition protocol and Agatston Scoring Method as used for a coronary artery calcium scan and is particularly attractive because it provides an assessment of the severity of AD, which is independent of the geometry and ventricular ejection fraction. Advances in the field of CT CVA measurement have been demonstrated in the last decade and are closely associated with hemodynamic measurements of moderate to severe AD in Doppler echocardiography, however, until recently, significant over-positioning of calcium from the aortic valve area among patients with hemodynamically severe AD and those with non-severe AD made it challenging to implement in clinical practice.
This development has generated significant interest in the use of CT-CVA as an alternative and complementary assessment of the severity of AD, especially in patients with discordant echocardiographic findings. (11) In fact: 1) CVA is strongly but non-linearly associated with hemodynamic measures of severity in moderate to severe AD (12). Thus, the determination of CVA may help discriminate severe AD from non-severe AD in patients with discordant findings measured by echocardiography, and 3) in patients with moderate to severe AD, CVA is also likely associated with faster progression of AD and with survival. However, it should be mentioned that the analysis of that series did not make adjustments to the calcium measured in the patients' coronary artery. Although the CVA score has been recommended in the European Society of Cardiology Guidelines to confirm the severity of AD in the following conditions 1) patients with low left ventricular ejection fraction (LVEF), gradient and low flow, in which dobutamine stress echocardiography is inconclusive and 2) patients with low gradient AD and preserved LVEF, and this is not yet part of the American Heart Association (AHA) and American College of Cardiology (ACC) guidelines (13).
So it has been suggested that clinical applicability should be established, so what are the next steps? While the reproducibility of coronary calcium quantification by multidetector CT has been tested for various workstation platforms before, (14,15) the same has not been done so far for CVA quantification through variability with standard Gold through the histopathological study and determine the variability of the CVA score measured by CT by determining its relationship through the flow and gradient status of patients with AD and define what implications can be suggested for the patient's treatment(13,16)
3. Problem statement.
There is a high prevalence of aortic valve calcification in patients who are subjected to valve change regardless of the cause (genetic, congenital, or degenerative structural malformation). Early identification of calcification in these patients is critical since they will receive a valve change that is likely to return to dysfunction if there is no history of the type of damage with or without preceding valve calcification. Currently, there is controversy about the ideal time to initiate valve therapy, as it has not been possible to identify those patients who will develop significant valve calcification. However, little is known about the relationship between the new imaging methods that are promising for measuring it and its correlation with standard gold, that is, what is quantified at the histopathological level.
3.1. Justification.
Magnitude: The global prevalence of aortic stenosis is 0.3-0.5% and 2-7% in \>65 years and of valvular calcification. According to its definition and criteria to classify valve stenosis, up to 30% will require aortic valve change due to valve insufficiency.
Significance: In the last two decades, the incidence of aortic valve insufficiency has increased exponentially and has been associated with unfavorable outcomes.
Vulnerability: Currently, the cornerstone of aortic stenosis management includes prevention and early support management. The identification of calcification has not been entirely clear either through laboratory parameters or about to with concerning risk factors, which are inadequate and late. Early detection and intervention of calcification during the disease can improve the prognosis if it is recognized early.
Feasibility: The study will be carried out in the two departments of Immunology through Dr. Soto who will coordinate the research) (Cardiovascular Medicine through Dr. Israel Pérez Torres who will evaluate calcification and histological changes in the valve tissue) (Pathology through Dr. Aranda who will manage and treat the valve samples) and the Image Department coordinated by Dr. Sergio Críales Vera who will quantify the valve calcium). All departments are recognized for their extensive participation in research.
The study of the pathogenesis of persistent inflammatory damage in aortic stenosis in relation to the type of prosthesis will lead in the future to evaluate if it is a factor involved in the recurrent damage in stenosis, calcification, and deterioration. In the last decades in Mexico, the demographic transition increased the number of people over 65 years old, the population in which the most significant complication of valve dysfunction has been seen. However, regardless of age and etiology, this is currently a population group with significant expansion and is expected to triple by 2030. This inflammatory damage will increase the prevalence of aortic stenosis, and therefore more patients will require valve replacement surgery.
Our Institute is a national reference hospital that attends a significant number of patients with aortic stenosis, among others. Of the valves that are implanted, a quarter is manufactured at the Institute. Therefore, evaluating processes highly related to valve dysfunction such as calcification is a priority and is considered a health problem that requires prevention.
3.2. Research question.
In patients who have undergone aortic valve surgery, will the quantification of calcium using the 4D computerized tomography method have a reasonable correlation with that measured by histopathology, and will it also allow it to be proposed as an early predictor of dysfunction?
4. Hypothesis.
Working hypothesis (H1): The quantifiable assessment of valve calcium by CT is similar to that measured by histopathology and predicts early valve dysfunction.
Null hypothesis (H0): The quantifiable assessment of calcium by CT scan is different from that measured by histopathology and does not predict early valve dysfunction.
5. Methodology.
5.1. Study design.
Cohort, observational, comparative, and prospective study.
5.2.5. Elimination criteria.
a) Not having an adequate sample or staining of the valve tissue.
5.3. Sample size.
For the calculation of the sample size, a determination of the sample size (two tails) shall be made, taking into account the means and standard deviation (SD) of the items corresponding to each one. All patients who meet the inclusion criteria described above shall be considered for evaluation during the period 2017-2020.
5.4. Data collection technique
Data collection will be divided into three stages:
Pre-surgical:
Once the study population has been identified, a personal interview will be conducted, the objective of the study will be explained to the patient, and informed consent will be obtained. Various echocardiographic parameters will be collected for each patient (pre-surgical echocardiogram). The study of the valve, which is requested before surgery, will be analyzed in a tomography scan, and this is the one that will be used to measure the calcium.
Post-surgery
Employing the sample of the valve tissue obtained from the surgery, the appropriate cuts and stains for the measurement of the calcium will be requested.
Echocardiographic study.
The echocardiographic study performed will be re-evaluated by two expert echocardiographers following current recommendations.16 The Philips iE33 xMATRIX (Philips, Andover Massachusetts) ultrasound system with X5-1 transducer. The dimensions of the left ventricle will be quantified in the long parasternal axis; the volumes of the left atrium and left ventricle will be calculated with the Simpson method. The aortic valve area will be estimated with the continuity equation. The mass of the LV was estimated with the Devereaux method.17 The mean and maximum transvalvular aortic gradients will be acquired in the apical projection of three or five chambers, where a suitable continuous Doppler spectrum and the highest transaortic velocity were obtained. The pulmonary artery systolic pressure will be estimated by adding the right atrial pressure to the tricuspid insufficiency gradient.
Computed tomography evaluation.
The study was performed with a multidetector with double energy source of 256 cuts definition Flash Medical Systems Forcheim Germany (128 x 2), performing prospective additive in the best diastolic phase (65-70 %), with 3 mm thick reconstructions and 3mm spacing with Kernel B 35f filter and visual field adjusted only to the heart. The images were processed on a workstation (SmartScore by Syngo via, Waukeesha WI Electronics for Medicine. The results were expressed in Agatston units. The study was carried out without a contrast medium and with a radiation equivalent to 1.0 mSv.
Tissue evaluation
Histological technique.
A 5-micron segment of the aortic valve, obtained by cardiothoracic surgery, was washed in 0.9% NaCl for 30 seconds immediately after the tissues were fixed by immersion in phosphate buffer with 10% formalin (pH 7.4) for 24 hours. Histological sections of the aortic valve were processed according to conventional histological procedures using Von Kossa staining. The technique is based on the reaction of silver nitrate in the presence of a reducing agent, usually, hydroquinone, resulting in insoluble silver phosphate that can be seen under the microscope in black. Histological sections were analyzed using a Carl Zeiss light microscope (Carl Zeiss, West Germany, Germany) (model 63,300) equipped with a Tucsen digital camera (9 megapixels) with TSview 7.1 software (Tucsen Imaging Technology Co., Ltd. Chuo, Japan, at 25x magnification. The photomicrographs were analyzed by densitometry using Sigma Scan Pro 5 Systat Software Inc. San Jose, California, CA, USA. Density values are expressed as pixel units.
6. Statistical analysis plan.
Categorical variables were expressed as proportions, continuous variables as means with standard deviation or median with interquartile range according to the distribution. Comparisons will be made for categorical variables with Chi-square or Fisher exact test and dimensional variables with Student t or Mann-Whitney U. Correlations with Pearson's r for quantitative variables or Spearman's rho for qualitative variables. Related samples were analyzed with ANOVA for repeated measurements and Friedman's test according to distribution with post-hoc analysis to identify differences between groups. The diagnostic test study will include the ROC curve to analyze cut-off points. The p-value of statistical significance was established to be less than 0.05 at two-tailed. Statistical analysis was performed with SPSS version 22 software (SPSS Inc. Chicago, Illinois).
Analysis and comparative evaluation of aortic calcium by computed tomography and histopathology in patients with aortic stenosis.
2. Background.
Calcified aortic valve disease (CAVD) was initially considered to be a passive degeneration of the extracellular matrix (EM). Recent studies have shown that within the development of the damage mechanism there is complexity and it is an active (1) and degenerative process where genetic, environmental and epigenetic phases overlap and interact leading to hemodynamic changes in blood flow, endothelial dysfunction and metabolic disorders that lead to low-density lipoprotein cholesterol deposits in the ME where at the same time there is an underlying infiltration of macrophages, oxidative stress, and release of pro-inflammatory cytokines. (2) However, although there are several theories of damage, and some of them are attributed to a diversity of origin such as genetic, congenital, infectious, and degenerative. Finally, the dynamic and functional impact of the heart affects equally. It leads to organic deterioration when the AD reaches clinical and echocardiographic criteria of severity, and the only therapeutic option is the change or replacement of the aortic valve.
The participation of imaging methods such as computerized tomography about to the concerning the aortic valve through the measurement of the aortic calcium score (AVC-CT) as a method to determine the severity of aortic stenosis (AS) in those cases where echocardiographic measurements are conflicting, allows us to see the interest in defining this problem through different angles of investigation (7). In AD, progressive calcification is the trigger factor that also predominantly leads to aortic valve obstruction. (3) Currently, such calcification can be easily quantified using the same acquisition protocol and Agatston Scoring Method as used for a coronary artery calcium scan and is particularly attractive because it provides an assessment of the severity of AD, which is independent of the geometry and ventricular ejection fraction. Advances in the field of CT CVA measurement have been demonstrated in the last decade and are closely associated with hemodynamic measurements of moderate to severe AD in Doppler echocardiography, however, until recently, significant over-positioning of calcium from the aortic valve area among patients with hemodynamically severe AD and those with non-severe AD made it challenging to implement in clinical practice.
This development has generated significant interest in the use of CT-CVA as an alternative and complementary assessment of the severity of AD, especially in patients with discordant echocardiographic findings. (11) In fact: 1) CVA is strongly but non-linearly associated with hemodynamic measures of severity in moderate to severe AD (12). Thus, the determination of CVA may help discriminate severe AD from non-severe AD in patients with discordant findings measured by echocardiography, and 3) in patients with moderate to severe AD, CVA is also likely associated with faster progression of AD and with survival. However, it should be mentioned that the analysis of that series did not make adjustments to the calcium measured in the patients' coronary artery. Although the CVA score has been recommended in the European Society of Cardiology Guidelines to confirm the severity of AD in the following conditions 1) patients with low left ventricular ejection fraction (LVEF), gradient and low flow, in which dobutamine stress echocardiography is inconclusive and 2) patients with low gradient AD and preserved LVEF, and this is not yet part of the American Heart Association (AHA) and American College of Cardiology (ACC) guidelines (13).
So it has been suggested that clinical applicability should be established, so what are the next steps? While the reproducibility of coronary calcium quantification by multidetector CT has been tested for various workstation platforms before, (14,15) the same has not been done so far for CVA quantification through variability with standard Gold through the histopathological study and determine the variability of the CVA score measured by CT by determining its relationship through the flow and gradient status of patients with AD and define what implications can be suggested for the patient's treatment(13,16)
3. Problem statement.
There is a high prevalence of aortic valve calcification in patients who are subjected to valve change regardless of the cause (genetic, congenital, or degenerative structural malformation). Early identification of calcification in these patients is critical since they will receive a valve change that is likely to return to dysfunction if there is no history of the type of damage with or without preceding valve calcification. Currently, there is controversy about the ideal time to initiate valve therapy, as it has not been possible to identify those patients who will develop significant valve calcification. However, little is known about the relationship between the new imaging methods that are promising for measuring it and its correlation with standard gold, that is, what is quantified at the histopathological level.
3.1. Justification.
Magnitude: The global prevalence of aortic stenosis is 0.3-0.5% and 2-7% in \>65 years and of valvular calcification. According to its definition and criteria to classify valve stenosis, up to 30% will require aortic valve change due to valve insufficiency.
Significance: In the last two decades, the incidence of aortic valve insufficiency has increased exponentially and has been associated with unfavorable outcomes.
Vulnerability: Currently, the cornerstone of aortic stenosis management includes prevention and early support management. The identification of calcification has not been entirely clear either through laboratory parameters or about to with concerning risk factors, which are inadequate and late. Early detection and intervention of calcification during the disease can improve the prognosis if it is recognized early.
Feasibility: The study will be carried out in the two departments of Immunology through Dr. Soto who will coordinate the research) (Cardiovascular Medicine through Dr. Israel Pérez Torres who will evaluate calcification and histological changes in the valve tissue) (Pathology through Dr. Aranda who will manage and treat the valve samples) and the Image Department coordinated by Dr. Sergio Críales Vera who will quantify the valve calcium). All departments are recognized for their extensive participation in research.
The study of the pathogenesis of persistent inflammatory damage in aortic stenosis in relation to the type of prosthesis will lead in the future to evaluate if it is a factor involved in the recurrent damage in stenosis, calcification, and deterioration. In the last decades in Mexico, the demographic transition increased the number of people over 65 years old, the population in which the most significant complication of valve dysfunction has been seen. However, regardless of age and etiology, this is currently a population group with significant expansion and is expected to triple by 2030. This inflammatory damage will increase the prevalence of aortic stenosis, and therefore more patients will require valve replacement surgery.
Our Institute is a national reference hospital that attends a significant number of patients with aortic stenosis, among others. Of the valves that are implanted, a quarter is manufactured at the Institute. Therefore, evaluating processes highly related to valve dysfunction such as calcification is a priority and is considered a health problem that requires prevention.
3.2. Research question.
In patients who have undergone aortic valve surgery, will the quantification of calcium using the 4D computerized tomography method have a reasonable correlation with that measured by histopathology, and will it also allow it to be proposed as an early predictor of dysfunction?
4. Hypothesis.
Working hypothesis (H1): The quantifiable assessment of valve calcium by CT is similar to that measured by histopathology and predicts early valve dysfunction.
Null hypothesis (H0): The quantifiable assessment of calcium by CT scan is different from that measured by histopathology and does not predict early valve dysfunction.
5. Methodology.
5.1. Study design.
Cohort, observational, comparative, and prospective study.
5.2.5. Elimination criteria.
a) Not having an adequate sample or staining of the valve tissue.
5.3. Sample size.
For the calculation of the sample size, a determination of the sample size (two tails) shall be made, taking into account the means and standard deviation (SD) of the items corresponding to each one. All patients who meet the inclusion criteria described above shall be considered for evaluation during the period 2017-2020.
5.4. Data collection technique
Data collection will be divided into three stages:
Pre-surgical:
Once the study population has been identified, a personal interview will be conducted, the objective of the study will be explained to the patient, and informed consent will be obtained. Various echocardiographic parameters will be collected for each patient (pre-surgical echocardiogram). The study of the valve, which is requested before surgery, will be analyzed in a tomography scan, and this is the one that will be used to measure the calcium.
Post-surgery
Employing the sample of the valve tissue obtained from the surgery, the appropriate cuts and stains for the measurement of the calcium will be requested.
Echocardiographic study.
The echocardiographic study performed will be re-evaluated by two expert echocardiographers following current recommendations.16 The Philips iE33 xMATRIX (Philips, Andover Massachusetts) ultrasound system with X5-1 transducer. The dimensions of the left ventricle will be quantified in the long parasternal axis; the volumes of the left atrium and left ventricle will be calculated with the Simpson method. The aortic valve area will be estimated with the continuity equation. The mass of the LV was estimated with the Devereaux method.17 The mean and maximum transvalvular aortic gradients will be acquired in the apical projection of three or five chambers, where a suitable continuous Doppler spectrum and the highest transaortic velocity were obtained. The pulmonary artery systolic pressure will be estimated by adding the right atrial pressure to the tricuspid insufficiency gradient.
Computed tomography evaluation.
The study was performed with a multidetector with double energy source of 256 cuts definition Flash Medical Systems Forcheim Germany (128 x 2), performing prospective additive in the best diastolic phase (65-70 %), with 3 mm thick reconstructions and 3mm spacing with Kernel B 35f filter and visual field adjusted only to the heart. The images were processed on a workstation (SmartScore by Syngo via, Waukeesha WI Electronics for Medicine. The results were expressed in Agatston units. The study was carried out without a contrast medium and with a radiation equivalent to 1.0 mSv.
Tissue evaluation
Histological technique.
A 5-micron segment of the aortic valve, obtained by cardiothoracic surgery, was washed in 0.9% NaCl for 30 seconds immediately after the tissues were fixed by immersion in phosphate buffer with 10% formalin (pH 7.4) for 24 hours. Histological sections of the aortic valve were processed according to conventional histological procedures using Von Kossa staining. The technique is based on the reaction of silver nitrate in the presence of a reducing agent, usually, hydroquinone, resulting in insoluble silver phosphate that can be seen under the microscope in black. Histological sections were analyzed using a Carl Zeiss light microscope (Carl Zeiss, West Germany, Germany) (model 63,300) equipped with a Tucsen digital camera (9 megapixels) with TSview 7.1 software (Tucsen Imaging Technology Co., Ltd. Chuo, Japan, at 25x magnification. The photomicrographs were analyzed by densitometry using Sigma Scan Pro 5 Systat Software Inc. San Jose, California, CA, USA. Density values are expressed as pixel units.
6. Statistical analysis plan.
Categorical variables were expressed as proportions, continuous variables as means with standard deviation or median with interquartile range according to the distribution. Comparisons will be made for categorical variables with Chi-square or Fisher exact test and dimensional variables with Student t or Mann-Whitney U. Correlations with Pearson's r for quantitative variables or Spearman's rho for qualitative variables. Related samples were analyzed with ANOVA for repeated measurements and Friedman's test according to distribution with post-hoc analysis to identify differences between groups. The diagnostic test study will include the ROC curve to analyze cut-off points. The p-value of statistical significance was established to be less than 0.05 at two-tailed. Statistical analysis was performed with SPSS version 22 software (SPSS Inc. Chicago, Illinois).
Conditions
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Aortic Calcification Valve
Aortic Valve Stenosis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. Patients who are candidates for aortic valve replacement.
2. Age greater than or equal to 18 years of age.
3. Both genders.
4. With any associated comorbidity
5. Any etiology
6. Hospitalized and with an echocardiographic study showing the variables to be studied
7. Informed Consent.
2. Age greater than or equal to 18 years of age.
3. Both genders.
4. With any associated comorbidity
5. Any etiology
6. Hospitalized and with an echocardiographic study showing the variables to be studied
7. Informed Consent.
Exclusion Criteria
1. Patients who have previously undergone other aortic valve surgery
2. Patients who have received contrast medium ≤24 hours.
3. Patients on hemodialysis.
4. Patients with infection.
5. Patients with cancer.
6. Patients with autoimmune diseases.
7. Pregnant women.
8. Patients who refuse to be included.
2. Patients who have received contrast medium ≤24 hours.
3. Patients on hemodialysis.
4. Patients with infection.
5. Patients with cancer.
6. Patients with autoimmune diseases.
7. Pregnant women.
8. Patients who refuse to be included.
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto Nacional de Cardiologia Ignacio Chavez
OTHER
Sponsor Role
lead
Responsible Party
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Maria Elena Soto, MsC and PhD
Deputy of the Immunology Department.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Instituto Nacional Ignacio Chavez
Mexico City, , Mexico
Site Status
Countries
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Mexico
References
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Otto CM, Kuusisto J, Reichenbach DD, Gown AM, O'Brien KD. Characterization of the early lesion of 'degenerative' valvular aortic stenosis. Histological and immunohistochemical studies. Circulation. 1994 Aug;90(2):844-53. doi: 10.1161/01.cir.90.2.844.
Reference Type
BACKGROUND
Soto ME, Salas JL, Vargas-Barron J, Marquez R, Rodriguez-Hernandez A, Bojalil-Parra R, Perez-Torres I, Guarner-Lans V. Pre- and post-surgical evaluation of the inflammatory response in patients with aortic stenosis treated with different types of prosthesis. BMC Cardiovasc Disord. 2017 Apr 14;17(1):100. doi: 10.1186/s12872-017-0526-1.
Reference Type
BACKGROUND
Pawade TA, Newby DE, Dweck MR. Calcification in Aortic Stenosis: The Skeleton Key. J Am Coll Cardiol. 2015 Aug 4;66(5):561-77. doi: 10.1016/j.jacc.2015.05.066.
Reference Type
BACKGROUND
Menon V, Lincoln J. The Genetic Regulation of Aortic Valve Development and Calcific Disease. Front Cardiovasc Med. 2018 Nov 6;5:162. doi: 10.3389/fcvm.2018.00162. eCollection 2018.
Reference Type
BACKGROUND
Kostyunin AE, Yuzhalin AE, Ovcharenko EA, Kutikhin AG. Development of calcific aortic valve disease: Do we know enough for new clinical trials? J Mol Cell Cardiol. 2019 Jul;132:189-209. doi: 10.1016/j.yjmcc.2019.05.016. Epub 2019 May 25.
Reference Type
BACKGROUND
Small A, Kiss D, Giri J, Anwaruddin S, Siddiqi H, Guerraty M, Chirinos JA, Ferrari G, Rader DJ. Biomarkers of Calcific Aortic Valve Disease. Arterioscler Thromb Vasc Biol. 2017 Apr;37(4):623-632. doi: 10.1161/ATVBAHA.116.308615. Epub 2017 Feb 2.
Reference Type
BACKGROUND
Chin CW, Pawade TA, Newby DE, Dweck MR. Risk Stratification in Patients With Aortic Stenosis Using Novel Imaging Approaches. Circ Cardiovasc Imaging. 2015 Aug;8(8):e003421. doi: 10.1161/CIRCIMAGING.115.003421. No abstract available.
Reference Type
BACKGROUND
Aggarwal SR, Clavel MA, Messika-Zeitoun D, Cueff C, Malouf J, Araoz PA, Mankad R, Michelena H, Vahanian A, Enriquez-Sarano M. Sex differences in aortic valve calcification measured by multidetector computed tomography in aortic stenosis. Circ Cardiovasc Imaging. 2013 Jan 1;6(1):40-7. doi: 10.1161/CIRCIMAGING.112.980052. Epub 2012 Dec 10.
Reference Type
BACKGROUND
Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA, Michelena HI, Cueff C, Larose E, Capoulade R, Vahanian A, Enriquez-Sarano M. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol. 2013 Dec 17;62(24):2329-38. doi: 10.1016/j.jacc.2013.08.1621. Epub 2013 Sep 24.
Reference Type
BACKGROUND
Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuellar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.
Reference Type
BACKGROUND
Glasziou P, Irwig L, Deeks JJ. When should a new test become the current reference standard? Ann Intern Med. 2008 Dec 2;149(11):816-22. doi: 10.7326/0003-4819-149-11-200812020-00009.
Reference Type
BACKGROUND
Messika-Zeitoun D, Aubry MC, Detaint D, Bielak LF, Peyser PA, Sheedy PF, Turner ST, Breen JF, Scott C, Tajik AJ, Enriquez-Sarano M. Evaluation and clinical implications of aortic valve calcification measured by electron-beam computed tomography. Circulation. 2004 Jul 20;110(3):356-62. doi: 10.1161/01.CIR.0000135469.82545.D0. Epub 2004 Jul 12.
Reference Type
BACKGROUND
Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
Reference Type
BACKGROUND
Ajlan M, Ahmed A, Alskaini AM, Abukhaled NF, Alsaileek A, Ajlan A, Sulaiman IF, Al-Mallah MH. The reproducibility of coronary artery calcium scoring on different software platforms. Int J Cardiol. 2015;187:155-6. doi: 10.1016/j.ijcard.2015.03.133. Epub 2015 Mar 19. No abstract available.
Reference Type
BACKGROUND
Weininger M, Ritz KS, Schoepf UJ, Flohr TG, Vliegenthart R, Costello P, Hahn D, Beissert M. Interplatform reproducibility of CT coronary calcium scoring software. Radiology. 2012 Oct;265(1):70-7. doi: 10.1148/radiol.12112532. Epub 2012 Jul 6.
Reference Type
BACKGROUND
Baumgartner H Chair, Hung J Co-Chair, Bermejo J, Chambers JB, Edvardsen T, Goldstein S, Lancellotti P, LeFevre M, Miller F Jr, Otto CM. Recommendations on the echocardiographic assessment of aortic valve stenosis: a focused update from the European Association of Cardiovascular Imaging and the American Society of Echocardiography. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):254-275. doi: 10.1093/ehjci/jew335.
Reference Type
BACKGROUND
Other Identifiers
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19-1139
Identifier Type: -
Identifier Source: org_study_id
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NCT03291925
UNKNOWN
NA
Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup
NCT05709652
RECRUITING
NA
Microcirculatory Status After Intravascular Lithotripsy
NCT05134051
COMPLETED
NA
Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenoses
NCT00817102
COMPLETED
NA
Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion
NCT03614559
UNKNOWN
Evaluation of FFR, WSS, and TPF Using CCTA
NCT01857687
UNKNOWN
Chronic Total Occlusion Registry
NCT04041921
TERMINATED
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
NCT04063345
UNKNOWN
PHASE2/PHASE3
Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT
NCT05973994
UNKNOWN
Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion
NCT04226326
COMPLETED
NA
Metabolic Determinants of the Progression of Aortic Stenosis
NCT01679431
UNKNOWN
Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions
NCT04145167
UNKNOWN
Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter
NCT05732025
UNKNOWN
NA
Evaluation of the Benefit of Exercise Testing for the Diagnosis of Obstruction in the Coronary Arteries of the Heart
NCT05140434
RECRUITING
Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions
NCT04960319
UNKNOWN
NA
Stereotaxis and Chronic Total Occlusion
NCT01980537
COMPLETED
NA
A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis
NCT07034157
RECRUITING
OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS)
NCT04375319
UNKNOWN
NA
Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography
NCT04426396
COMPLETED
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
NCT06369142
RECRUITING
NA
TECTONIC CAD IVL IDE Study
NCT06885177
RECRUITING
NA
Ultrasonic Cardiogram Evaluate the Prognosis of Percutaneous Revascularization of Chronic Total Occlusions
NCT03300011
UNKNOWN
NA
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
NCT02234804
UNKNOWN
NA
Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation
NCT05218694
RECRUITING
NA