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

• Conditions: Healthy Volunteer
• Interventions: 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

• Registration Number: NCT03372616
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-29
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-09
• Last Update Submitted: 2017-12-09
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13
• Study Start: 2018-01
• Primary Completion: 2018-03
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Invasive left ventricular diastolic function assessment	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.
All participants	Non-Invasive left ventricular diastolic function assessment	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.
All participants	Invasive aortic blood pressure measurement	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.
All participants	Non-Invasive aortic blood pressure measurement	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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.
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.
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.
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.