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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415948
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : December 18, 2009
Information provided by:

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

Condition or disease Intervention/treatment
Acute Coronary Syndrome (ACS) Device: Biomarkers

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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement
Study Start Date : December 2006
Actual Study Completion Date : June 2008

Biospecimen Retention:   Samples Without DNA
Plasma Specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting the to the ED within 6 hours with symptoms consistent with ACS.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415948

United States, California
UC Davis
Sacramento, California, United States
United States, Connecticut
Yale University
New Haven, Connecticut, United States
United States, Maryland
St Agnes Hospital
Baltimore, Maryland, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Ingham Regional Medical Center
Lansing, Michigan, United States
United States, New York
New York Methodist Hosptial
Brooklyn, New York, United States
SUNY Stony Brook
Stony Brook, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Hopsital
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Sponsors and Collaborators
Principal Investigator: Frank Peacock, MD The Cleveland Clinic Identifier: NCT00415948     History of Changes
Other Study ID Numbers: BSTE-0101
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: December 2009

Keywords provided by Biosite:
Acute Coronary Syndrome
Sample Procurement

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases