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

Acute Coronary Syndrome (ACS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415948
• Other study ID #: BSTE-0101
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: December 17, 2009
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: December 2009
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Syndrome

Intervention

Device:
• Biomarkers

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States,