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

December 17, 2009 updated by: Biosite
The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

300

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
    • California
      • Sacramento, California, United States
        • UC Davis
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale University
    • Maryland
      • Baltimore, Maryland, United States
        • St Agnes Hospital
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States
        • Brigham & Women's Hospital
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States
        • Spectrum Health Hospitals
      • Lansing, Michigan, United States
        • Ingham Regional Medical Center
    • New York
      • Brooklyn, New York, United States
        • New York Methodist Hosptial
      • Stony Brook, New York, United States
        • SUNY Stony Brook
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States
        • Ohio State University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia
      • Norfolk, Virginia, United States
        • Sentara Norfolk General Hopsital
      • Richmond, Virginia, United States
        • Virginia Commonwealth University Medical Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting the to the ED within 6 hours with symptoms consistent with ACS.

Description

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

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

Collaborators and Investigators

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

Sponsor

Biosite

Investigators

  • Principal Investigator: Frank Peacock, MD, The Cleveland Clinic

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

December 1, 2006

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 23, 2006

First Posted (Estimate)

December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

December 18, 2009

Last Update Submitted That Met QC Criteria

December 17, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSTE-0101

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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