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Data Aquisition for Optimization of Coronary Artery Disease Algorithm

NCT ID: NCT01090947

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

729 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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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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Detailed Description

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

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients referred to CAG.

Sequential design with ProtoCAD and CAG

ProtoCAD

Intervention Type DEVICE

Aquiring acoustic signals from heart patients.

Interventions

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ProtoCAD

Aquiring acoustic signals from heart patients.

Intervention Type DEVICE

Other Intervention Names

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Acarix CAD device.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Acarix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Clemmensen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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University Hospital of Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CP002IN

Identifier Type: -

Identifier Source: org_study_id

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