Severe Coronary Artery Disease (S-CAD) Clinical Trial
— SCOREOfficial title:
SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
| NCT number | NCT01053975 |
| Other study ID # | CM-102-005 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | January 20, 2010 |
| Last updated | November 5, 2010 |
| Start date | February 2010 |
| Verified date | November 2010 |
| Source | Spirocor |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 1000 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Cardiovascular Associates | Birmingham | Alabama |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | MUSC | Charleston | South Carolina |
| United States | Cardiovascular Associates of the DE Valley - Cherry Hill | Cherry Hill | New Jersey |
| United States | The Linder Center for Research & Education | Cincinnati | Ohio |
| United States | Clearwater Cardiovascular & Interventional Consultants | Clearwater | Florida |
| United States | Cardiovascular Specialists of Central Maryland, PA | Columbia | Maryland |
| United States | Cardiovascular Associates, DE Valley- Elmer | Elmer | New Jersey |
| United States | North Ohio Research Ltd | Elyria | Ohio |
| United States | Escondido Cardiology Associates | Escondido | California |
| United States | Phoenix Heart, PLLC | Glendale | Arizona |
| United States | Pentucket Medical Associates | Haverhill | Massachusetts |
| United States | Heart Center Research | Huntsville | Alabama |
| United States | University Of Iowa Hospital, Lipid Research Clinic | Iowa City | Iowa |
| United States | Clearwater Cardiovascular & Interventional Consultants | Largo | Florida |
| United States | South Denver Heart Cardiology Associates | Littleton | Colorado |
| United States | Cardiovascular Associates | Louisville | Kentucky |
| United States | Catholic Medical Center | Manchester | New Hampshire |
| United States | Cardiovascular Research Center of South Florida | Miami | Florida |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Minneapolis VAMC | Minneapolis | Minnesota |
| United States | Christiana Care Health Services | Newark | Delaware |
| United States | Cardiac & Endovascular Associates | Ridgewood | New Jersey |
| United States | Clearwater Cardiovascular & Interventional Consultants | Safety Harbor | Florida |
| United States | Sanford Cardiology, a division of Pinehurst Medical, Inc. | Sanford | North Carolina |
| United States | Cardiovascular Associates, DE Valley- Sewell | Sewell | New Jersey |
| United States | Cardiovascular Associates of East Texas | Tyler | Texas |
| United States | Cardiac Diagnostic Associates, PC | York | Pennsylvania |
| United States | Humility of Mary Health Partners dba, St. Elizabeth Health Center | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Spirocor |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | RSR vs. S-ECG in subjects suspected with S-CAD | 3 weeks window | No |