SPIROCOR Coronary Outcome by Respiratory Stress Examination

Stopped early

Conditions studied: Severe Coronary Artery Disease (S-CAD)

In brief

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.

Key facts

Study ID

NCT01053975

Run by

Spirocor

People needed

1000

Starts

2010-02-01

Last updated by the study team

2010-11-08

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardiovascular Associates — Birmingham, Alabama, 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 — Clearwater, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants — Largo, Florida, United States
• Cardiovascular Research Center of South Florida — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants — Safety Harbor, Florida, United States
• University Of Iowa Hospital, Lipid Research Clinic — Iowa City, Iowa, United States
• Cardiovascular Associates — Louisville, Kentucky, United States
• Cardiovascular Specialists of Central Maryland, PA — Columbia, Maryland, United States
• Pentucket Medical Associates — Haverhill, Massachusetts, United States
• Minneapolis VAMC — Minneapolis, Minnesota, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Cardiovascular Associates of the DE Valley - Cherry Hill — Cherry Hill, New Jersey, United States
• Cardiovascular Associates, DE Valley- Elmer — Elmer, New Jersey, United States
• Cardiac & Endovascular Associates — Ridgewood, New Jersey, United States
• Cardiovascular Associates, DE Valley- Sewell — Sewell, New Jersey, United States
• Sanford Cardiology, a division of Pinehurst Medical, Inc. — Sanford, North Carolina, United States
• The Linder Center for Research & Education — Cincinnati, Ohio, United States
• North Ohio Research Ltd — Elyria, Ohio, United States

Full record on ClinicalTrials.gov

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