SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)

November 5, 2010 updated by: Spirocor

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
RSR vs. S-ECG in subjects suspected with S-CAD
Time Frame: 3 weeks window
3 weeks window

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spirocor

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ron Waksman, MD, Medstar Health Research Institute
  • Principal Investigator: William Weintraub, MD, Christiana Care Health Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM-102-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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