SPIROCOR Coronary Outcome by Respiratory Stress Examination - Full Text View

SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)

This study is currently recruiting participants.

Verified by Spirocor, August 2010

First Received: January 20, 2010 Last Updated: August 5, 2010 History of Changes

Sponsor:	Spirocor
Information provided by:	Spirocor
ClinicalTrials.gov Identifier:	NCT01053975

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:

MedlinePlus related topics: Coronary Artery Disease

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

Contacts

Contact: Rebecca Torguson	202-877-2194	Rebecca.Torguson@Medstar.net
Contact: Kimberly Kaneshige	202- 877-2959	Kimberly.Kaneshige@MedStar.net

Show 25 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:	Christiana Care Health Services ( Dr. William Weintraub )
ClinicalTrials.gov Identifier:	NCT01053975 History of Changes
Other Study ID Numbers:	CM-102-005
Study First Received:	January 20, 2010
Last Updated:	August 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
Coronary Disease
Myocardial Ischemia
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 02, 2010