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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03372616
Acronym
MATCHY
Enrollment
100
Registered
2017-12-13
Start date
2018-01-31
Completion date
2018-06-30
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

aortic blood pressure, diastolic dysfuntion, echocardiography, left ventricular ejection fraction

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.

Interventions

DIAGNOSTIC_TESTInvasive left ventricular diastolic function assessment

Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.

DIAGNOSTIC_TESTInvasive aortic blood pressure measurement

Aortic blood pressure will be measured with polyethylene catheter in aortic root.

DIAGNOSTIC_TESTNon-Invasive left ventricular diastolic function assessment

Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.

DIAGNOSTIC_TESTNon-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.

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular filling pressure assessment with left heart catheterization1 dayAll participants will receive invasive left ventricular filling pressure assessment with left heart catheterization.
Left ventricular diastolic function assessment with echocardiography using ASE recommendations1 dayAll 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.
Left ventricular diastolic function assessment with echocardiography using EACVI recommendations1 dayAll 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

MeasureTime frameDescription
Aortic blood presure obtained with Sphygmocor device1 daySphygmocor device (AtCor Medical, Australia) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.
Aortic blood presure obtained with catheterization1 dayCatheterization will be used in invasive aortic blood presure measurement. The cather will be placed in the aortic root while measuring the blood pressure.
Aortic blood presure obtained with PulsePen device1 dayPulsePen device (DiaTecne SRL, Italy) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.
Aortic blood presure obtained with Mobil-O-Graph device1 dayMobil-O-Graph (IEM, Germany) device will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

Contacts

Primary ContactChen Chi, M.D.
chichen.david@gmail.com086-150-2178-7802
Backup ContactYi Zhang, M.D., Ph.D.
yizshcn@gmail.com086-189-1768-6332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026