coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants (MATCHY)

coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants: the MATCHY Study

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteer
• Intervention / Treatment: Diagnostic test: Invasive left ventricular diastolic function assessment; Diagnostic test: Invasive aortic blood pressure measurement; Diagnostic test: Non-Invasive left ventricular diastolic function assessment; Diagnostic test: Non-Invasive aortic blood pressure measurement

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with proposed coronary angiography and left left ventriculography but without diagnosed cardiovascular disease.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Invasive left ventricular diastolic function assessment; Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.; Diagnostic test: Invasive aortic blood pressure measurement; Aortic blood pressure will be measured with polyethylene catheter in aortic root.; Diagnostic test: Non-Invasive left ventricular diastolic function assessment; Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular filling pressure assessment with left heart catheterization	All participants will receive invasive left ventricular filling pressure assessment with left heart catheterization.	1 day
Left ventricular diastolic function assessment with echocardiography using ASE recommendations	All participants will receive non-invasive left ventricular diastolic function assessment with echocardiography. The ASE-recommended (American Society of Echocardiography) creteria would be used to define left ventricular diastolic dysfunction.	1 day
Left ventricular diastolic function assessment with echocardiography using EACVI recommendations	All participants will receive non-invasive left ventricular diastolic function assessment with echocardiography. The EACVI-recommended (European Association of Cardiovascular Imaging) creteria would be used to define left ventricular diastolic dysfunction.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic blood presure obtained with Sphygmocor device	Sphygmocor device (AtCor Medical, Australia) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.	1 day
Aortic blood presure obtained with PulsePen device	PulsePen device (DiaTecne SRL, Italy) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.	1 day
Aortic blood presure obtained with Mobil-O-Graph device	Mobil-O-Graph (IEM, Germany) device will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.	1 day
Aortic blood presure obtained with catheterization	Catheterization will be used in invasive aortic blood presure measurement. The cather will be placed in the aortic root while measuring the blood pressure.	1 day

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Yawei Xu, M.D., Ph.D., Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: December 9, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 9, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: echocardiography; left ventricular ejection fraction; aortic blood pressure; diastolic dysfuntion
• Other Study ID Numbers: MATCHY2017YZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No