The Ischemia Modified Albumin In Diagnosing Ischemic New Events

NCT ID: NCT00355992

Last Updated: 2009-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Disease, Ischemic Ischemia, Myocardial Ischemic Heart Disease Unstable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inverness Medical Innovations

INDUSTRY

Sponsor Role lead

Responsible Party

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Inverness Medical Innovations

Principal Investigators

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James L Januzzi, M.D.

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dartmouth Medical Center

Lebanon, New Hampshire, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 21835288 (View on PubMed)

Other Identifiers

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IMA-0106-001.04

Identifier Type: -

Identifier Source: org_study_id

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