This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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)
Information provided by:
Spirocor Identifier:
First received: January 20, 2010
Last updated: November 5, 2010
Last verified: November 2010
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.

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

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 ]

Estimated Enrollment: 1000
Study Start Date: February 2010

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01053975

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

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

Keywords provided by Spirocor:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on August 18, 2017