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

• Sponsor: Shanghai 10th People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03372616
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants: the MATCHY Study
• Anticipated Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Left ventricular filling pressure assessment with left heart catheterization [1 day]

   All participants will receive invasive left ventricular filling pressure assessment with left heart catheterization.

2. Left ventricular diastolic function assessment with echocardiography using ASE recommendations [1 day]

   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.

3. Left ventricular diastolic function assessment with echocardiography using EACVI recommendations [1 day]

   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.

Secondary Outcome Measures

1. Aortic blood presure obtained with Sphygmocor device [1 day]

   Sphygmocor device (AtCor Medical, Australia) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

2. Aortic blood presure obtained with PulsePen device [1 day]

   PulsePen device (DiaTecne SRL, Italy) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

3. Aortic blood presure obtained with Mobil-O-Graph device [1 day]

   Mobil-O-Graph (IEM, Germany) device will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

4. Aortic blood presure obtained with catheterization [1 day]

   Catheterization will be used in invasive aortic blood presure measurement. The cather will be placed in the aortic root while measuring the blood pressure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai 10th People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.

• Responsible Party: Ya-Wei Xu, Chief director of department of cardiology, Shanghai 10th People's Hospital
• ClinicalTrials.gov Identifier: NCT03372616
• Other Study ID Numbers: MATCHY2017YZ
• First Posted: Dec 13, 2017
• Last Update Posted: Dec 13, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ya-Wei Xu, Chief director of department of cardiology, Shanghai 10th People's Hospital: aortic blood pressure; diastolic dysfuntion; echocardiography; left ventricular ejection fraction

Study Results

No Results Posted as of Dec 13, 2017