Trial Outcomes & Findings for Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm (NCT NCT01564628)
NCT ID: NCT01564628
Last Updated: 2019-08-19
Results Overview
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.
COMPLETED
306 participants
Heart sound recordings measured on testday (25 minutes study period)
2019-08-19
Participant Flow
Participant milestones
| Measure |
Site 1A Population - CAD-score/CTA/CAG
Site 1A study population. Subject to CAD-score, CTA and, if relevant, CAG investigation.
|
Site 2 Population - CAD-score/CAG
Site 2 study population. Subject to CAD-score and CAG investigation
|
Site 1B Population - CAD-score/CTA/CAG
Site 1B study population. Subject to CAD-score, CTA and, if relevant, CAG investigation
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
58
|
63
|
|
Overall Study
COMPLETED
|
181
|
56
|
61
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm
Baseline characteristics by cohort
| Measure |
All Study Participants
n=298 Participants
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).
|
|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=99 Participants
|
|
Region of Enrollment
Denmark
|
298 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Heart sound recordings measured on testday (25 minutes study period)Population: Per protocol analysis
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.
Outcome measures
| Measure |
All Study Participants
n=298 Participants
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).
|
|---|---|
|
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
|
73.4 percentage of 100
Interval 66.2 to 80.0
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60