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OpenTrials
Completed

NCT Number: NCT01090947

Data Aquisition for Optimization of Coronary Artery Disease Algorithm

The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Copenhagen

Copenhagen, 2100, Denmark

About this study

Acoustic information from the heart is obtained from patients suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age minimum 18 years
  • Referred to CAG on suspicion of CAD
  • Stabile angina without ACS
  • Signed informed consent

Exclusion criteria

  • ACS
  • Previous bypass operation
  • Previous heart transplant(incl. mechanical or artificial)
  • Pregnancy
  • Damaged skin on examination location

Treatment and study plan

ProtoCAD

Device

Aquiring acoustic signals from heart patients.

Other names: Acarix CAD device.

Primary outcomes

  1. Sensitivity versus 1-specificity as a function of cut-off values on the 'Cardiac Noise Marker' scale here under Sensitivity by suitable cut-off value on the 'Cardiac Noise Marker' scale and Specificity with same cut-off value.

    Time frame: The first testday

Secondary outcomes

  1. Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups.

    Time frame: The first testday

Sponsors and collaborators

Lead sponsor

Acarix

Industry

Collaborators

  • Rigshospitalet, Denmark

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2010
Registry last updated
Mar 15, 2019

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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