PRV-KORO: PRV-based Detection of CAD in Comparison to Standard Methods

Sponsor

University Medicine Greifswald (Other)

Overall Status

Completed

CT.gov ID

NCT02404948

Collaborator

(none)

156

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: Diagnostic algorithm

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 Design

Study Type:

Observational

Actual Enrollment :

156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Comparison of a Pulse Wave Based Approach for Detection of Coronary Artery Disease Compared to Standard Methods

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jun 1, 2017

Outcome Measures

Primary Outcome Measures

Presence of CAD - angio (minimum 1 stenosis >=50%) [1 day]
Presence of CAD in coronary angiography: minimum 1 stenosis >=50%

Secondary Outcome Measures

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
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)
Global longitudinal strain (2D and 3D echocardiography) [1 day]
Global longitudinal strain (2D and 3D echocardiography)
Abnormal cardiogoniometry [1 day]
Abnormal results of cardiogoniometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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