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

This study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00415948
First received: December 21, 2006
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

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 Intervention
Acute Coronary Syndrome (ACS)
Device: Biomarkers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement

Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA

Plasma Specimens


Estimated Enrollment: 300
Study Start Date: December 2006
Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415948

Locations
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
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's 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
Biosite
Investigators
Principal Investigator: Frank Peacock, MD The Cleveland Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415948     History of Changes
Other Study ID Numbers: BSTE-0101
Study First Received: December 21, 2006
Last Updated: December 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
Heart
Cardiac
Acute Coronary Syndrome
Sample Procurement

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014