coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants
NCT ID: NCT03372616
Last Updated: 2017-12-13
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
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UNKNOWN
100 participants
OBSERVATIONAL
2018-01-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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All participants
Aortic blood pressure, LV filling pressrue, and LV volume will be measured in all participants. Meanwhile, echocardiography and non-invasive aortic blood presure measurement will be performed. Three devices will be used in non-invasive aortic blood presure measurement, including Sphygmocor (AtCor Medical, Australia), PulsePen (DiaTecne SRL, Italy), and Mobil-O-Graph (IEM, Germany). In conclusion, all participants will receive invasive and non-invasive left ventricular diastolic function assessment, together with invasive and non-invasive aortic blood pressure assessment.
Invasive left ventricular diastolic function assessment
Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.
Invasive aortic blood pressure measurement
Aortic blood pressure will be measured with polyethylene catheter in aortic root.
Non-Invasive left ventricular diastolic function assessment
Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.
Non-Invasive aortic blood pressure measurement
Three devices (Sphygmocor \[AtCor Medical, Australia\], PulsePen \[DiaTecne SRL, Italy\], and Mobil-O-Graph \[IEM, Germany\] ) will be used to assess aortic blood pressure non-invasively when participants are undergoing invasive aortic blood pressure measurement.
Interventions
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Invasive left ventricular diastolic function assessment
Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.
Invasive aortic blood pressure measurement
Aortic blood pressure will be measured with polyethylene catheter in aortic root.
Non-Invasive left ventricular diastolic function assessment
Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.
Non-Invasive aortic blood pressure measurement
Three devices (Sphygmocor \[AtCor Medical, Australia\], PulsePen \[DiaTecne SRL, Italy\], and Mobil-O-Graph \[IEM, Germany\] ) will be used to assess aortic blood pressure non-invasively when participants are undergoing invasive aortic blood pressure measurement.
Eligibility Criteria
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Inclusion Criteria
* Agree to participate the study and sign informed written consent;
* Any change of drugs which effect the hemodynamics during 1 month prior to enrollment;
* Proposed to perform coronary angiography and left left ventriculography in hospital;
Exclusion Criteria
* Identified coronary artery disease via coronary angiography;
* Diagnosed pulmonary vascular or parenchymal disease;
* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
* Stenosis or insufficiency of valves (moderate and above);
* Heart transplant;
* Congenital heart disease;
* Inadequate imaging or doppler parameter quality in echocardiography.
18 Years
ALL
Yes
Sponsors
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Shanghai 10th People's Hospital
OTHER
Responsible Party
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Ya-Wei Xu
Chief director of department of cardiology
Principal Investigators
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Yawei Xu, M.D., Ph.D.
Role: STUDY_CHAIR
Shanghai 10th People's Hospital
Central Contacts
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References
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Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
Handoko ML, Paulus WJ. Polishing the diastolic dysfunction measurement stick. Eur J Echocardiogr. 2008 Sep;9(5):575-7. doi: 10.1093/ejechocard/jen181. Epub 2008 Jun 11. No abstract available.
McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson IB. Central blood pressure: current evidence and clinical importance. Eur Heart J. 2014 Jul;35(26):1719-25. doi: 10.1093/eurheartj/eht565. Epub 2014 Jan 23.
Other Identifiers
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MATCHY2017YZ
Identifier Type: -
Identifier Source: org_study_id