NCT01053975

Terminated

SPIROCOR Coronary Outcome by Respiratory Stress Examination

Spirocor Source

Spirocor

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

CM-102-005

Study Type

observational

Estimated enrollment

1,000

Locations

1 country

Sites

29

Timeline

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 1,000 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 29 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 20, 2010
Actual (reported)
First Posted
January 22, 2010
Actual (reported)
Study Start
February 2010
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: November 8, 2010
Status Verified: November 2010
Last Update Submitted: November 5, 2010

Conditions

Severe Coronary Artery Disease (S-CAD)

Keywords

RSRSECGSPECTQCASCAD

Outcome Measures

Primary Outcomes (1)

RSR vs. S-ECG in subjects suspected with S-CAD
3 weeks window

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

Subject with suspected S-CAD

Sponsors & Collaborators

Spirocor
Industrylead

Study Sites (29)

Cardiovascular Associates

Birmingham, Alabama, 35213, United States

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Heart Center Research

Huntsville, Alabama, 35801, United States

Phoenix Heart, PLLC

Glendale, Arizona, 85306, United States

Escondido Cardiology Associates

Escondido, California, 92025, United States

South Denver Heart Cardiology Associates

Littleton, Colorado, 80120, United States

Christiana Care Health Services

Newark, Delaware, 19718, United States

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

William Weintraub, MD
Christiana Care Health Systems
PRINCIPAL INVESTIGATOR
Ron Waksman, MD
Medstar Health Research Institute
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

November 8, 2010

Record last verified: 2010-11

Subject able to perform the guided breathing protocol and comply with study requirements

Subject is able and agrees to sign the informed consent form

You may not qualify if:

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

Contact the study team to confirm eligibility.

Clearwater Cardiovascular & Interventional Consultants

Clearwater, Florida, 33756, United States

Clearwater Cardiovascular & Interventional Consultants

Largo, Florida, 33777, United States

Cardiovascular Research Center of South Florida

Miami, Florida, 33173, United States

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Clearwater Cardiovascular & Interventional Consultants

Safety Harbor, Florida, 34695, United States

University Of Iowa Hospital, Lipid Research Clinic

Iowa City, Iowa, 52242, United States

Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Cardiovascular Specialists of Central Maryland, PA

Columbia, Maryland, 21044, United States

Pentucket Medical Associates

Haverhill, Massachusetts, 01830, United States

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Cardiovascular Associates of the DE Valley - Cherry Hill

Cherry Hill, New Jersey, 08034, United States

Cardiovascular Associates, DE Valley- Elmer

Elmer, New Jersey, 08318, United States

Cardiac & Endovascular Associates

Ridgewood, New Jersey, 07450, United States

Cardiovascular Associates, DE Valley- Sewell

Sewell, New Jersey, 08080, United States

Sanford Cardiology, a division of Pinehurst Medical, Inc.

Sanford, North Carolina, 27330, United States

The Linder Center for Research & Education

Cincinnati, Ohio, 45219, United States

North Ohio Research Ltd

Elyria, Ohio, 44035, United States

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

Youngstown, Ohio, 44501, United States

Cardiac Diagnostic Associates, PC

York, Pennsylvania, 17405, United States

MUSC

Charleston, South Carolina, 29425, United States

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01053975
Data provider: ClinicalTrials.gov
Source updated: 2010-11-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:21 UTC

Locations

US(29)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations