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TerminatedNCT00355992IMAgineUpdated May 12, 2009

The Ischemia Modified Albumin In Diagnosing Ischemic New Events

An observational study in Heart Disease, Ischemic, Ischemia, Myocardial and Ischemic Heart Disease, sponsored by Inverness Medical Innovations. Terminated at 5 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2009-05-12.

Sponsored by Inverness Medical Innovations · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,250
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Myocardial Ischemia
  • Chest pain
  • Ischemia Modified Albumin
  • Acute Coronary Syndrome
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 1,250 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Inverness Medical Innovations is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,250 participants (estimated)
06

Study locations

5 sites
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
  • Dartmouth Medical Center
    Lebanon, New Hampshire, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Vanderbilt University
    Nashville, Tennessee, United States
  • Hamilton General Hospital
    Hamilton, Ontario L8L2X2, Canada
07

References and documents

Publications

  • 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. PubMed 21835288 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00355992
Lead sponsor
Inverness Medical Innovations
First posted
Jul 25, 2006
Start date
Sep 2006
Completion
Dec 2007 (estimated)
Last update
May 12, 2009

Study contacts

James L Januzzi, M.D.
study director · Massachusetts General Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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