Clinical trial NCT00355992: The Ischemia Modified Albumin In Diagnosing Ischemic New Events
Official title: The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAGINE Study).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Disease, Ischemic
Ischemia, Myocardial
Ischemic Heart Disease
Unstable Angina
Keywords: Myocardial Ischemia
Chest pain
Ischemia Modified Albumin
Acute Coronary Syndrome
Lead sponsor: Inverness Medical Innovations
Sponsor class: INDUSTRY
First posted: 2006-07-25
Enrollment: 1250
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present in the emergency department at the listed institutions with suspected ischemic signs and or symptoms (chest pain) will be eligible for participation in the study as long as they meet inclusion and exclusion criteria and sign an informed consent.

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Medical Center
state: New Hampshire
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Massachusetts General Hospital
name: James L Januzzi, M.D.
role: STUDY_DIRECTOR
References:
citation: Bhardwaj A, Truong QA, Peacock WF, Yeo KT, Storrow A, Thomas S, Curtis KM, Foote RS, Lee HK, Miller KF, Januzzi JL Jr. A multicenter comparison of established and emerging cardiac biomarkers for the diagnostic evaluation of chest pain in the emergency department. Am Heart J. 2011 Aug;162(2):276-282.e1. doi: 10.1016/j.ahj.2011.05.022.