NCT01090947

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
729

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 18, 2010

Last Update Submit

March 14, 2019

Conditions

Coronary Artery Disease

Outcome Measures

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.

    The first testday

Secondary Outcomes (1)

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

    The first testday

Study Arms (1)

Patients referred to CAG.

Sequential design with ProtoCAD and CAG

Device: ProtoCAD

Interventions

ProtoCADDEVICE

Aquiring acoustic signals from heart patients.

Also known as: Acarix CAD device.
Patients referred to CAG.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to CAG.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Peter Clemmensen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 23, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

DK(1)