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SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053975
Recruitment Status : Terminated (Based on analyses of studies separately of the SCORE study, sponsor has decided to discontinue the Study. Data collected during the study will not be analyzed)
First Posted : January 22, 2010
Last Update Posted : November 8, 2010
Information provided by:

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.

Condition or disease
Severe Coronary Artery Disease (S-CAD)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
Study Start Date : February 2010

Primary Outcome Measures :
  1. RSR vs. S-ECG in subjects suspected with S-CAD [ Time Frame: 3 weeks window ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects referred to cardology clinics for evaluation of severe coronary artery disease (S-CAD)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053975

  Show 29 Study Locations
Sponsors and Collaborators
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Principal Investigator: William Weintraub, MD Christiana Care Health Systems
Principal Investigator: Ron Waksman, MD Washington Hospital Center

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Responsible Party: Dr. William Weintraub, Christiana Care Health Services Identifier: NCT01053975     History of Changes
Other Study ID Numbers: CM-102-005
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: November 8, 2010
Last Verified: November 2010

Keywords provided by Spirocor:

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases