N/A
Completed N=306
Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm
Source: ClinicalTrials.gov NCT01564628 ↗Enrolled (actual)
306
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. — 73.4 percentage of 100
Summary
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. |
73.4 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease
- Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome
- Subject is willing to adhere to the study procedure
- Has signed the informed consent form and authorization to registration and publication of health information
Exclusion Criteria
- Has acute coronary syndrome or stroke
- Arterial fibrillation
- Known severe arrhythmia or resting heart rate above 85 bpm
- Known diastolic murmurs due to heart valve disease
- Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart
- Reduced ejection fraction < 50%
- Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma)
- Inability to perform CT-angio and/or subsequent CAG
- In active treatment for any cancer
- In active treatment for immunosuppression after transplantation
- Established or pursuing pregnancy or breast feeding
- Has damaged skin on the spot where the patch is placed during the recordings.
Data sourced from ClinicalTrials.gov (NCT01564628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.