Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement

NCT ID: NCT00415948

Last Updated: 2009-12-18

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

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).

Detailed Description

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This is a prospective, multi-center, observational, and sample procurement study of adult subjects presenting to an Emergency Department (ED) in whom ACS is in the differential diagnosis. Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset, and must have experienced at least 30 minutes of chest discomfort. Those ED patients with possible ACS who meet the inclusion/exclusion criteria will be approached for study enrollment by trained research personnel.

The patient's diagnostic work-up and treatment will continue per the standards of the treating institution. As indicated by their clinical presentation, all subjects in the study will have objective cardiac testing for evidence of coronary artery disease (CAD) during or in close proximity to the index ED visit or hospital admission. For this study, objective cardiac testing will consist of one of the following tests: exercise treadmill, coronary angiography, myocardial stress imaging, stress magnetic resonance imaging (MRI), sestamibi scan, or dobutamine echocardiogram. Cardiac events and procedures, such as angioplasty-stenting and coronary artery bypass surgery (CABG), will be recorded during the index ED visit, hospitalization and post-hospital follow-up period. Subjects will have a 30-day and 6-month follow-up contact by phone to collect this information on cardiac events, procedures, and survival.

Conditions

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Acute Coronary Syndrome (ACS)

Keywords

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Heart Cardiac Acute Coronary Syndrome Sample Procurement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biomarkers

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older at time of enrollment
* Patient presenting to the ED within 6 hours or less from symptom (chest discomfort consistent with possible ACS) onset
* Patient experiencing at least 30 minutes of chest discomfort, consistent with possible ACS, from time of symptom onset; patients who have symptoms of shorter duration due to pharmacologic intervention may be included
* Physician plans to perform objective cardiac testing as defined by the protocol

Exclusion Criteria

* Patient (or legal representative) unable or unwilling to provide informed consent
* Patient (or legal representative) refusal of medical record review or telephone follow-up at 30 days or 6 months
* Patient (or legal representative) refusal of multiple blood sample collection over the study period
* Prisoners or other institutionalized individuals
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott RDx Cardiometabolic

OTHER

Sponsor Role lead

Principal Investigators

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Frank Peacock, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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UC Davis

Sacramento, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

St Agnes Hospital

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Site Status

Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status

New York Methodist Hosptial

Brooklyn, New York, United States

Site Status

SUNY Stony Brook

Stony Brook, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Sentara Norfolk General Hopsital

Norfolk, Virginia, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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BSTE-0101

Identifier Type: -

Identifier Source: org_study_id