Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement
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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 |
Plasma Specimens
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2006 |
| Study Completion Date: | June 2008 |
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 |
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
Contacts and 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 | |
| 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:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013