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

June 29, 2018 updated by: Marcus Doerr, University Medicine Greifswald

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • Marcus Dörr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred to first coronary angiography due to suspected CAD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of CAD - angio (minimum 1 stenosis >=50%)
Time Frame: 1 day
Presence of CAD in coronary angiography: minimum 1 stenosis >=50%
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
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)
1 day
Wall motion index - echo (Wall motion index (2D and 3D echocardiography)
Time Frame: 1 day
Wall motion index (2D and 3D echocardiography)
1 day
Global longitudinal strain (2D and 3D echocardiography)
Time Frame: 1 day
Global longitudinal strain (2D and 3D echocardiography)
1 day
Abnormal cardiogoniometry
Time Frame: 1 day
Abnormal results of cardiogoniometry
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRV-Koro-Study-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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