Clinical trial NCT03372616: coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants
Official title: coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants: the MATCHY Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Volunteer
Keywords: aortic blood pressure
diastolic dysfuntion
echocardiography
left ventricular ejection fraction
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proposed coronary angiography and left left ventriculography but without diagnosed cardiovascular disease.

Brief summary: This is a cross-sectional cohort study which aims to compare the invasive and non-invasive assessments on aortic blood pressure and cardiac funtion in subjects without history of cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood pressure will be measured invasively. Non-invasive assessment includes echocardiography,aortic, and carotid blood pressure measurement.


Eligibility criteria: Inclusion Criteria:

* Over or equal to 18 years old;
* 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:

* Non-sinus rhythm or frequent extra systoles;
* 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.

Primary outcomes:
measure: Left ventricular filling pressure assessment with left heart catheterization
timeFrame: 1 day
measure: Left ventricular diastolic function assessment with echocardiography using ASE recommendations
timeFrame: 1 day
measure: Left ventricular diastolic function assessment with echocardiography using EACVI recommendations
timeFrame: 1 day
Secondary outcomes:
measure: Aortic blood presure obtained with Sphygmocor device
timeFrame: 1 day
measure: Aortic blood presure obtained with PulsePen device
timeFrame: 1 day
measure: Aortic blood presure obtained with Mobil-O-Graph device
timeFrame: 1 day
measure: Aortic blood presure obtained with catheterization
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.