Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Occlusion
Conditions
Brief summary
The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.
Detailed description
This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.
Interventions
DEVICECAD-det
CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.
Sponsors
Ottawa Heart Institute Research Corporation
AusculSciences Canada Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
CAD-det
Eligibility
Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Stable 2. \>/= 19 years old 3. Suspected obstructive CAD 4. Referred to ICA
Exclusion criteria
1. Documented CAD or coronary revascularization 2. Age \< 19 years old 3. Acute coronary syndromes 4. Congenital heart disease or heart transplantation 5. Dextrocardia 6. Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (\>10/minute)) 7. Resting heart rate \> 110 bpm 8. Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy 9. Chest wall deformity or wounds in adhesive application areas 10. Pregnancy 11. Unwillingness or inability to provide informed consent or to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CAD-det to validate: | up to 1 Year | CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAD-det to detect: | up to 1 year | 1. Obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50% stratified according to sex (men and women). 2. Severity of CAD by QCA: 1. 0 - 25% diameter stenosis (Negative for obstructive CAD); 2. 25 - 50% diameter stenosis (Negative for obstructive CAD); 3. 50 - 69% diameter stenosis (Positive for obstructive CAD); 4. 70% or greater diameter stenosis (Positive for obstructive CAD); and 5. Equivocal or non-diagnostic. |
Countries
Canada
Contacts
Primary ContactMelissa Spero, CRN, CCRP
Backup ContactJohn Phillips, BSc.
Outcome results
None listed