Clinical trial NCT01053975: SPIROCOR Coronary Outcome by Respiratory Stress Examination
Official title: SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Coronary Artery Disease (S-CAD)
Keywords: RSR
SECG
SPECT
QCA
SCAD
Lead sponsor: Spirocor
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects referred to cardology clinics for evaluation of severe coronary artery disease (S-CAD)

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.


Eligibility 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

Primary outcomes:
measure: RSR vs. S-ECG in subjects suspected with S-CAD
timeFrame: 3 weeks window
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Glendale
country: United States
facility: Phoenix Heart, PLLC
state: Arizona
city: Escondido
country: United States
facility: Escondido Cardiology Associates
state: California
city: Littleton
country: United States
facility: South Denver Heart Cardiology Associates
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Clearwater
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants
state: Florida
city: Largo
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Safety Harbor
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants
state: Florida
city: Iowa City
country: United States
facility: University Of Iowa Hospital, Lipid Research Clinic
state: Iowa
city: Louisville
country: United States
facility: Cardiovascular Associates
state: Kentucky
city: Columbia
country: United States
facility: Cardiovascular Specialists of Central Maryland, PA
state: Maryland
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Cherry Hill
country: United States
facility: Cardiovascular Associates of the DE Valley - Cherry Hill
state: New Jersey
city: Elmer
country: United States
facility: Cardiovascular Associates, DE Valley- Elmer
state: New Jersey
city: Ridgewood
country: United States
facility: Cardiac & Endovascular Associates
state: New Jersey
city: Sewell
country: United States
facility: Cardiovascular Associates, DE Valley- Sewell
state: New Jersey
city: Sanford
country: United States
facility: Sanford Cardiology, a division of Pinehurst Medical, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: The Linder Center for Research & Education
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research Ltd
state: Ohio
city: Youngstown
country: United States
facility: Humility of Mary Health Partners dba, St. Elizabeth Health Center
state: Ohio
city: York
country: United States
facility: Cardiac Diagnostic Associates, PC
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
Study officials:
affiliation: Christiana Care Health Systems
name: William Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References: