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The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAgine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355992
Recruitment Status : Terminated
First Posted : July 25, 2006
Last Update Posted : May 12, 2009
Information provided by:
Inverness Medical Innovations

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

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Study Type : Observational
Estimated 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 : September 2006
Estimated Study Completion Date : December 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00355992

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New Hampshire
Dartmouth Medical Center
Lebanon, New Hampshire, United States
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Inverness Medical Innovations
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Study Director: James L Januzzi, M.D. Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bob Parson, Inverness Medical Innovations Identifier: NCT00355992    
Other Study ID Numbers: IMA-0106-001.04
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: May 2009
Keywords provided by Inverness Medical Innovations:
Myocardial Ischemia
Chest pain
Ischemia Modified Albumin
Acute Coronary Syndrome
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Angina, Unstable
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations