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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>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<br>* Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.<br>Diagnostic Test: Invasive aortic blood pressure measurement<br>* Aortic blood pressure will be measured with polyethylene catheter in aortic root.<br>Diagnostic Test: Non-Invasive left ventricular diastolic function assessment<br>* Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.<br>Diagnostic Test: Non-Invasive aortic blood pressure measurement<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic blood pressure, diastolic dysfuntion, echocardiography, left ventricular ejection fraction