Severe Coronary Artery Disease (S-CAD)
Conditions
Keywords
RSR, SECG, SPECT, QCA, SCAD
Brief summary
The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD.
Interventions
None listed
Sponsors
Spirocor
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with suspected S-CAD * Subject able to perform the guided breathing protocol and comply with study requirements * Subject is able and agrees to sign the informed consent form
Exclusion criteria
* Resting (supine) ECG evidence of ST-segment depression ≥ 1 mm in any lead or left bundle branch block or significant arrhythmia * Current digoxin therapy * Subject has severe valvular heart disease * Subject has congestive heart failure NYHA class III/IV * Subject has known history of myocardial infarction (ST elevation or non ST elevation) * Subject had previous coronary revascularization: CABG or PCI * Subject has pacemaker or ICD that controls sinus * Morbidly obese subject (BMI ≥ 40) * Subject has any significant medical condition which, at the investigator's discretion, may interfere with the subject's optimal participation in the study; and * Subject is currently participating in another investigational product clinical study that the investigator believes may interfere with the outcome of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RSR vs. S-ECG in subjects suspected with S-CAD | 3 weeks window |
Countries
United States
Outcome results
None listed