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SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)

This study has been 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)
Sponsor:
Information provided by:
Spirocor
ClinicalTrials.gov Identifier:
NCT01053975
First received: January 20, 2010
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  Purpose

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
Severe Coronary Artery Disease (S-CAD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spirocor:

Primary Outcome Measures:
  • RSR vs. S-ECG in subjects suspected with S-CAD [ Time Frame: 3 weeks window ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: February 2010
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects referred to cardology clinics for evaluation of severe coronary artery disease (S-CAD)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053975

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

No publications provided

Responsible Party: Dr. William Weintraub, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01053975     History of Changes
Other Study ID Numbers: CM-102-005
Study First Received: January 20, 2010
Last Updated: November 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Spirocor:
RSR
SECG
SPECT
QCA
SCAD

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

ClinicalTrials.gov processed this record on May 23, 2013