SPIROCOR Coronary Outcome by Respiratory Stress Examination
- Conditions
- Severe Coronary Artery Disease (S-CAD)
- Registration Number
- NCT01053975
- Lead Sponsor
- Spirocor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RSR vs. S-ECG in subjects suspected with S-CAD 3 weeks window
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Minneapolis VAMC
🇺🇸Minneapolis, Minnesota, United States
South Denver Heart Cardiology Associates
🇺🇸Littleton, Colorado, United States
Cardiovascular Associates
🇺🇸Louisville, Kentucky, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
Escondido Cardiology Associates
🇺🇸Escondido, California, United States
Phoenix Heart, PLLC
🇺🇸Glendale, Arizona, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Cardiovascular Research Center of South Florida
🇺🇸Miami, Florida, United States
Cardiovascular Associates of the DE Valley - Cherry Hill
🇺🇸Cherry Hill, New Jersey, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Cardiovascular Associates, DE Valley- Elmer
🇺🇸Elmer, New Jersey, United States
Pentucket Medical Associates
🇺🇸Haverhill, Massachusetts, United States
Cardiovascular Associates, DE Valley- Sewell
🇺🇸Sewell, New Jersey, United States
North Ohio Research Ltd
🇺🇸Elyria, Ohio, United States
Cardiac Diagnostic Associates, PC
🇺🇸York, Pennsylvania, United States
Humility of Mary Health Partners dba, St. Elizabeth Health Center
🇺🇸Youngstown, Ohio, United States
MUSC
🇺🇸Charleston, South Carolina, United States
Clearwater Cardiovascular & Interventional Consultants
🇺🇸Safety Harbor, Florida, United States
Cardiovascular Specialists of Central Maryland, PA
🇺🇸Columbia, Maryland, United States
Cardiovascular Associates of East Texas
🇺🇸Tyler, Texas, United States
University Of Iowa Hospital, Lipid Research Clinic
🇺🇸Iowa City, Iowa, United States
The Linder Center for Research & Education
🇺🇸Cincinnati, Ohio, United States
Cardiac & Endovascular Associates
🇺🇸Ridgewood, New Jersey, United States
Sanford Cardiology, a division of Pinehurst Medical, Inc.
🇺🇸Sanford, North Carolina, United States