IMAgine: The Ischemia Modified Albumin In Diagnosing Ischemic New Events

Sponsor

Inverness Medical Innovations (Industry)

Overall Status

Terminated

CT.gov ID

NCT00355992

Collaborator

(none)

1,250

Enrollment

Locations

Duration (Months)

250

Patients Per Site

16.7

Patients Per Site Per Month

Study Details

Study Description

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 evaluate the diagnostic and prognostic implication for IMA for major adverse cardiac events.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease, Ischemic Ischemia, Myocardial Ischemic Heart Disease Unstable Angina

Study Design

Study Type:

Observational

Anticipated Enrollment :

1250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAGINE Study).

Study Start Date :

Sep 1, 2006

Anticipated Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L2X2