PRV-based Detection of CAD in Comparison to Standard Methods

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02404948
• Lead Sponsor: University Medicine Greifswald

Brief Summary

This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.

Detailed Description

The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose \>=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-26
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Primary Completion: 2016-07
• Study Completion: 2017-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Coronary angiography indication present
• informed written consent

Exclusion Criteria

• Previous coronary angiography
• Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery)
• atrial fibrillation (at time of measurement)
• severe ventricular extrasystole (e.g. >=10% ventricular extrasystoles, bigemina)
• pregnancy, lactation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of CAD - angio (minimum 1 stenosis >=50%)	1 day	Presence of CAD in coronary angiography: minimum 1 stenosis \>=50%

Secondary Outcome Measures

Name	Time	Method
Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography)	1 day	Presence of wall motion abnormality in at least 1 segment (2D echocardiography)
Wall motion index - echo (Wall motion index (2D and 3D echocardiography)	1 day	Wall motion index (2D and 3D echocardiography)
Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)	1 day	Number of coronary vessels with at least 1 stenosis \>=50% in coronary angiography
Global longitudinal strain (2D and 3D echocardiography)	1 day	Global longitudinal strain (2D and 3D echocardiography)
Abnormal cardiogoniometry	1 day	Abnormal results of cardiogoniometry

Trial Locations

Locations (1)

Marcus Dörr; 🇩🇪 Greifswald, Germany