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

Healthy Volunteer Clinical Trial

— MATCHY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03372616
• Other study ID #: MATCHY2017YZ
• Status: Not yet recruiting
• Phase: N/A
• First received: October 29, 2017
• Last updated: December 9, 2017
• Start date: January 2018
• Est. completion date: June 2018

Study information

• Verified date: December 2017
• Source: Shanghai 10th People's Hospital
• Contact: Chen Chi, M.D.
• Phone: 086-150-2178-7802
• Email: chichen.david[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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