PRV-based Detection of CAD in Comparison to Standard Methods

Overview

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.

Full Title of Study: “Comparison of a Pulse Wave Based Approach for Detection of Coronary Artery Disease Compared to Standard Methods”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2016

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Presence of CAD – angio (minimum 1 stenosis >=50%)
    • Time Frame: 1 day
    • Presence of CAD in coronary angiography: minimum 1 stenosis >=50%

Secondary Measures

  • Presence of CAD number – angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 1 day
    • Wall motion index (2D and 3D echocardiography)
  • Global longitudinal strain (2D and 3D echocardiography)
    • Time Frame: 1 day
    • Global longitudinal strain (2D and 3D echocardiography)
  • Abnormal cardiogoniometry
    • Time Frame: 1 day
    • Abnormal results of cardiogoniometry

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Medicine Greifswald
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marcus Doerr, Professor – University Medicine Greifswald

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.