An observational study in Coronary Artery Disease, sponsored by Acarix. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Acarix · Observational
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).
Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 306 is close to the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Acarix is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred to examination for Coronary Artery Disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).
Device: CADScor1
Acoustic recording
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values. The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients. CAD and non-CAD patients are defined by the CTA and CAG evaluations.
Time frame: Heart sound recordings measured on testday (25 minutes study period)
| Milestone | Site 1A Population - CAD-score/CTA/CAG | Site 2 Population - CAD-score/CAG | Site 1B Population - CAD-score/CTA/CAG |
|---|---|---|---|
| Started | 185 | 58 | 63 |
| Completed | 181 | 56 | 61 |
| Not completed | 4 | 2 | 2 |
Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values. The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients. CAD and non-CAD patients are defined by the CTA and CAG evaluations.
| percentage of 100 | All Study Participants |
|---|---|
| The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. | 73.4 (66.2 to 80.0) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/298 (0%) | 0/298 (0%) | 0/298 (0%) |
PP population.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 62.3 ± 10.4 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 138 |
| Male | 160 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| Denmark | 298 |
The record gives a start of Mar 2012, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2019, 5 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Acarix