SPIROCOR Coronary Outcome by Respiratory Stress Examination

NCT ID: NCT01053975

Last Updated: 2010-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Coronary Artery Disease (S-CAD)

Keywords

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RSR SECG SPECT QCA SCAD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spirocor

INDUSTRY

Sponsor Role lead

Responsible Party

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Christiana Care Health Services

Principal Investigators

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William Weintraub, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Cardiovascular Associates

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Heart Center Research

Huntsville, Alabama, United States

Site Status

Phoenix Heart, PLLC

Glendale, Arizona, United States

Site Status

Escondido Cardiology Associates

Escondido, California, United States

Site Status

South Denver Heart Cardiology Associates

Littleton, Colorado, United States

Site Status

Christiana Care Health Services

Newark, Delaware, United States

Site Status

Clearwater Cardiovascular & Interventional Consultants

Clearwater, Florida, United States

Site Status

Clearwater Cardiovascular & Interventional Consultants

Largo, Florida, United States

Site Status

Cardiovascular Research Center of South Florida

Miami, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Clearwater Cardiovascular & Interventional Consultants

Safety Harbor, Florida, United States

Site Status

University Of Iowa Hospital, Lipid Research Clinic

Iowa City, Iowa, United States

Site Status

Cardiovascular Associates

Louisville, Kentucky, United States

Site Status

Cardiovascular Specialists of Central Maryland, PA

Columbia, Maryland, United States

Site Status

Pentucket Medical Associates

Haverhill, Massachusetts, United States

Site Status

Minneapolis VAMC

Minneapolis, Minnesota, United States

Site Status

Catholic Medical Center

Manchester, New Hampshire, United States

Site Status

Cardiovascular Associates of the DE Valley - Cherry Hill

Cherry Hill, New Jersey, United States

Site Status

Cardiovascular Associates, DE Valley- Elmer

Elmer, New Jersey, United States

Site Status

Cardiac & Endovascular Associates

Ridgewood, New Jersey, United States

Site Status

Cardiovascular Associates, DE Valley- Sewell

Sewell, New Jersey, United States

Site Status

Sanford Cardiology, a division of Pinehurst Medical, Inc.

Sanford, North Carolina, United States

Site Status

The Linder Center for Research & Education

Cincinnati, Ohio, United States

Site Status

North Ohio Research Ltd

Elyria, Ohio, United States

Site Status

Humility of Mary Health Partners dba, St. Elizabeth Health Center

Youngstown, Ohio, United States

Site Status

Cardiac Diagnostic Associates, PC

York, Pennsylvania, United States

Site Status

MUSC

Charleston, South Carolina, United States

Site Status

Cardiovascular Associates of East Texas

Tyler, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CM-102-005

Identifier Type: -

Identifier Source: org_study_id