Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement
- Conditions
- Acute Coronary Syndrome (ACS)
- Registration Number
- NCT00415948
- Lead Sponsor
- Abbott RDx Cardiometabolic
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
St Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
UC Davis
🇺🇸Sacramento, California, United States
Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
SUNY Stony Brook
🇺🇸Stony Brook, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hopsital
🇺🇸Norfolk, Virginia, United States
New York Methodist Hosptial
🇺🇸Brooklyn, New York, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States