PRV-based Detection of CAD in Comparison to Standard Methods

Coronary Artery Disease Clinical Trial

— PRV-KORO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404948
• Other study ID #: PRV-Koro-Study-001
• Status: Completed
• Start date: April 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Diagnostic algorithm
Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.

Locations

Country	Name	City	State
Germany	Marcus Dörr	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of CAD - angio (minimum 1 stenosis >=50%)	Presence of CAD in coronary angiography: minimum 1 stenosis >=50%	1 day
Secondary	Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)	Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography	1 day
Secondary	Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography)	Presence of wall motion abnormality in at least 1 segment (2D echocardiography)	1 day
Secondary	Wall motion index - echo (Wall motion index (2D and 3D echocardiography)	Wall motion index (2D and 3D echocardiography)	1 day
Secondary	Global longitudinal strain (2D and 3D echocardiography)	Global longitudinal strain (2D and 3D echocardiography)	1 day
Secondary	Abnormal cardiogoniometry	Abnormal results of cardiogoniometry	1 day