SPIROCOR Coronary Outcome by Respiratory Stress Examination

Terminated

• 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

Study Timeline

• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-22
• Study Start: 2010-02
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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

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

Trial Locations

Locations (26)

Cardiovascular Associates; 🇺🇸 Louisville, Kentucky, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Heart Center Research; 🇺🇸 Huntsville, Alabama, United States

Phoenix Heart, PLLC; 🇺🇸 Glendale, Arizona, United States

Escondido Cardiology Associates; 🇺🇸 Escondido, California, United States

South Denver Heart Cardiology Associates; 🇺🇸 Littleton, Colorado, United States

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Clearwater Cardiovascular & Interventional Consultants; 🇺🇸 Safety Harbor, Florida, United States

Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Cardiovascular Research Center of South Florida; 🇺🇸 Miami, Florida, United States

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