SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)

SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study

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.

Study Overview

• Status: Terminated
• Conditions: Severe Coronary Artery Disease (S-CAD)

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35213
      • Cardiovascular Associates
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Phoenix Heart, PLLC
  • California
    • Escondido, California, United States, 92025
      • Escondido Cardiology Associates
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Heart Cardiology Associates
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular & Interventional Consultants
    • Largo, Florida, United States, 33777
      • Clearwater Cardiovascular & Interventional Consultants
    • Miami, Florida, United States, 33173
      • Cardiovascular Research Center of South Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Safety Harbor, Florida, United States, 34695
      • Clearwater Cardiovascular & Interventional Consultants
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University Of Iowa Hospital, Lipid Research Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Cardiovascular Associates
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Cardiovascular Specialists of Central Maryland, PA
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
      • Pentucket Medical Associates
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VAMC
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Cardiovascular Associates of the DE Valley - Cherry Hill
    • Elmer, New Jersey, United States, 08318
      • Cardiovascular Associates, DE Valley- Elmer
    • Ridgewood, New Jersey, United States, 07450
      • Cardiac & Endovascular Associates
    • Sewell, New Jersey, United States, 08080
      • Cardiovascular Associates, DE Valley- Sewell
  • North Carolina
    • Sanford, North Carolina, United States, 27330
      • Sanford Cardiology, a division of Pinehurst Medical, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Linder Center for Research & Education
    • Elyria, Ohio, United States, 44035
      • North Ohio Research Ltd
    • Youngstown, Ohio, United States, 44501
      • Humility of Mary Health Partners dba, St. Elizabeth Health Center
  • Pennsylvania
    • York, Pennsylvania, United States, 17405
      • Cardiac Diagnostic Associates, PC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Texas
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associates of East Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RSR vs. S-ECG in subjects suspected with S-CAD	3 weeks window

Collaborators and Investigators

• Sponsor: Spirocor
• Investigators: Principal Investigator: Ron Waksman, MD, MedStar Health Research Institute; Principal Investigator: William Weintraub, MD, Christiana Care Health Systems

Study record dates

Study Major Dates

• Study Start: February 1, 2010

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): November 7, 2010
• Last Update Submitted That Met QC Criteria: November 5, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: SPECT; SCAD; QCA; RSR; SECG
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CM-102-005