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Completed

NCT Number: NCT02404948

PRV-based Detection of CAD in Comparison 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marcus Dörr

Greifswald, 17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic algorithm

Other

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

Primary outcomes

  1. Presence of CAD - angio (minimum 1 stenosis >=50%)

    Time frame: 1 day

    Presence of CAD in coronary angiography: minimum 1 stenosis >=50%

Secondary outcomes

  1. 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

  2. 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)

  3. Wall motion index - echo (Wall motion index (2D and 3D echocardiography)

    Time frame: 1 day

    Wall motion index (2D and 3D echocardiography)

  4. Global longitudinal strain (2D and 3D echocardiography)

    Time frame: 1 day

    Global longitudinal strain (2D and 3D echocardiography)

  5. Abnormal cardiogoniometry

    Time frame: 1 day

    Abnormal results of cardiogoniometry

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: PRV-KORO

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 1, 2015
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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