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

This study has been terminated.
Sponsor:
Information provided by:
Inverness Medical Innovations
ClinicalTrials.gov Identifier:
NCT00355992
First received: June 27, 2006
Last updated: May 11, 2009
Last verified: May 2009
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAGINE Study).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inverness Medical Innovations:

Estimated Enrollment: 1250
Study Start Date: September 2006
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355992

Locations
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
Investigators
Study Director: James L Januzzi, M.D. Massachusetts General Hospital
  More Information

No publications provided by Inverness Medical Innovations

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bob Parson, Inverness Medical Innovations
ClinicalTrials.gov Identifier: NCT00355992     History of Changes
Other Study ID Numbers: IMA-0106-001.04
Study First Received: June 27, 2006
Last Updated: May 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Inverness Medical Innovations:
Myocardial Ischemia
Chest pain
Ischemia Modified Albumin
Acute Coronary Syndrome

Additional relevant MeSH terms:
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
 Chest Pain
Pain
Signs and Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013