Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients
NCT ID: NCT00723281
Last Updated: 2019-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
18 participants
OBSERVATIONAL
2007-01-31
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Our current protocol at UCSF for heart transplant patients involves screening with stress tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of the lumen of the coronary arteries and to assess wall thickness.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates
NCT00727051
Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients
NCT01753505
Coronary Artery Disease Screening in Kidney Transplant Candidates
NCT02082483
Diagnostic Performance of Coronary CT Angiography With CT FFR in Kidney Transplantation Candidates
NCT03248674
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
NCT06234410
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specific Aim 1- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.
Specific Aim 2- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall thickness, vessel area and luminal area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.
Secondary Aim - To asses the correlation of cross-sectional vessel wall area, vessel wall thickness, vessel area, luminal area and vessel wall index with global and regional left ventricular function using coronary CTA.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients must be 18 years of age or older.
3. Any ethnic background is acceptable.
Exclusion Criteria
2. Patients with heart rate higher than 65 bpm and contraindications for the use of beta-blockers, listed below:
Systolic blood pressure \< 90mmHg Decompensated congestive heart failure; COPD or asthma in use of bronchodilator; Second or third degree heart block; Severe aortic stenosis, defined by a pressure gradient higher than 50 mmHg and/or the presence of symptoms.
3. Patients with contraindications for the use of nitroglycerin, listed below:
Severe anemia; Increased intracranial pressure; Known hypersensitivity; Use of Sildenafil Citrate (Viagra®)
4. Children and pregnant women will be excluded because of risks associated with radiation exposure.
5. Patients must have no atrial fibrillation, as this will interfere with cardiac gating for the examination.
6. Patients unable to give informed consent will be excluded as well.
7. Patients with a coronary stent placed.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
American Roentgen Ray Society
OTHER
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karen Ordovas
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles B Higgins, MD
Role: PRINCIPAL_INVESTIGATOR
UCSF Department of Radiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSF Medical Center
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mehra MR, Ventura HO, Chambers R, Collins TJ, Ramee SR, Kates MA, Smart FW, Stapleton DD. Predictive model to assess risk for cardiac allograft vasculopathy: an intravascular ultrasound study. J Am Coll Cardiol. 1995 Nov 15;26(6):1537-44. doi: 10.1016/0735-1097(95)00357-6.
Zakliczynski M, Swierad M, Zakliczynska H, Maruszewski M, Buszman P, Zembala M. Usefulness of stanford scale of intimal hyperplasia assessed by intravascular ultrasound to predict time of onset and severity of cardiac allograft vasculopathy. Transplant Proc. 2005 Mar;37(2):1343-5. doi: 10.1016/j.transproceed.2004.12.143.
Leber AW, Becker A, Knez A, von Ziegler F, Sirol M, Nikolaou K, Ohnesorge B, Fayad ZA, Becker CR, Reiser M, Steinbeck G, Boekstegers P. Accuracy of 64-slice computed tomography to classify and quantify plaque volumes in the proximal coronary system: a comparative study using intravascular ultrasound. J Am Coll Cardiol. 2006 Feb 7;47(3):672-7. doi: 10.1016/j.jacc.2005.10.058. Epub 2006 Jan 6.
Moselewski F, Ropers D, Pohle K, Hoffmann U, Ferencik M, Chan RC, Cury RC, Abbara S, Jang IK, Brady TJ, Daniel WG, Achenbach S. Comparison of measurement of cross-sectional coronary atherosclerotic plaque and vessel areas by 16-slice multidetector computed tomography versus intravascular ultrasound. Am J Cardiol. 2004 Nov 15;94(10):1294-7. doi: 10.1016/j.amjcard.2004.07.117.
Sigurdsson G, Carrascosa P, Yamani MH, Greenberg NL, Perrone S, Lev G, Desai MY, Garcia MJ. Detection of transplant coronary artery disease using multidetector computed tomography with adaptative multisegment reconstruction. J Am Coll Cardiol. 2006 Aug 15;48(4):772-8. doi: 10.1016/j.jacc.2006.04.082. Epub 2006 Jul 25.
Gregory SA, Ferencik M, Achenbach S, Yeh RW, Hoffmann U, Inglessis I, Cury RC, Nieman K, McNulty IA, Laffan JA, Pomerantsev EV, Brady TJ, Semigran MJ, Jang IK. Comparison of sixty-four-slice multidetector computed tomographic coronary angiography to coronary angiography with intravascular ultrasound for the detection of transplant vasculopathy. Am J Cardiol. 2006 Oct 1;98(7):877-84. doi: 10.1016/j.amjcard.2006.04.027. Epub 2006 Aug 4.
Ferencik M, Moselewski F, Ropers D, Hoffmann U, Baum U, Anders K, Pomerantsev EV, Abbara S, Brady TJ, Achenbach S. Quantitative parameters of image quality in multidetector spiral computed tomographic coronary imaging with submillimeter collimation. Am J Cardiol. 2003 Dec 1;92(11):1257-62. doi: 10.1016/j.amjcard.2003.08.003.
Obuchowski NA. Estimating and comparing diagnostic tests' accuracy when the gold standard is not binary. Acad Radiol. 2005 Sep;12(9):1198-204. doi: 10.1016/j.acra.2005.05.013.
Obuchowski NA. An ROC-type measure of diagnostic accuracy when the gold standard is continuous-scale. Stat Med. 2006 Feb 15;25(3):481-93. doi: 10.1002/sim.2228.
Efron B, Tibshirani R. An Introduction to the Bootstrap. New York: Chapman and Hall; 1993
Kish. Survey Sampling. New York: Wiley & Sons; 1965.
Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5.
Pannu HK, Alvarez W Jr, Fishman EK. Beta-blockers for cardiac CT: a primer for the radiologist. AJR Am J Roentgenol. 2006 Jun;186(6 Suppl 2):S341-5. doi: 10.2214/AJR.04.1944.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H627-29905
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.