Status:
TERMINATED
The Ischemia Modified Albumin In Diagnosing Ischemic New Events
Lead Sponsor:
Inverness Medical Innovations
Conditions:
Heart Disease, Ischemic
Ischemia, Myocardial
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for risk stratification in patients presenting with chest discomfort and possible ischemic heart disease, and to ...
Eligibility Criteria
Inclusion
- Patients with primary complaints of chest discomfort or patients with symptoms indicative of a moderate to high probability for unstable angina clinically indicated reason for evaluation for ACS in the Emergency Department meeting tyhe following inclusion criteria will be enrolled:
- Age \>=21 years
- Presentation within two hours of relief of most recent episode of chest pain or presence of on-going symptoms suggestive of coronary ischemia, which should be at least 10 minutes in duration.
- Patients being evaluated for suspected ischemic signs and or symptoms (chest pain) at the time of presentation according to routine standard of care institutional chest pain protocol/pathway.
Exclusion
- Administration of thrombolytic medication prior to first (presentation) blood draw
- Acute coronary syndrome (ACS) secondary to supply/demand inequity (i.e. known anemia, tachycardia, - defined as HR greater than 150 bpm, known sepsis, hypotension, defined as blood pressure \< 90 mmHg).
- Established diagnosis of liver cirrhosis
- Other acute ischemic sources (ongoing severe claudication, mesenteric ischemia, acute TIA/CVA)
- Renal failure requiring dialysis
- Greater than 2 hours from relief of the most recent episode of chest pain or signs and symptoms suggestive of coronary ischemia.
- Chest pain following traumatic injury to the chest
- Evidence for sever systemic infection, manifesting as fever (temperature \>100 degrees) and systolic blood pressure \<100 mmHg
- Patients unwilling or unable to provide written consent, without available next of kin
- Cocaine-related chest pain
- Pregnancy
- Known diagnosis of active malignancy
- Acute Bowel Ischemia
- Severe peripheral vascular disease
- Acute brain ischemia
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT00355992
Start Date
September 1 2006
End Date
December 1 2007
Last Update
May 12 2009
Active Locations (5)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States
2
Dartmouth Medical Center
Lebanon, New Hampshire, United States
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Vanderbilt University
Nashville, Tennessee, United States