SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)

Spirocor

Status: Terminated

Conditions: Severe Coronary Artery Disease (S-CAD)

Study type: Observational

Funder types: Industry

Identifiers

NCT01053975

CM-102-005

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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