NCT00355992

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2006

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 12, 2009

Status Verified

May 1, 2009

First QC Date

June 27, 2006

Last Update Submit

May 11, 2009

Conditions

Heart Disease, IschemicIschemia, MyocardialIschemic Heart DiseaseUnstable Angina

Keywords

Myocardial IschemiaChest painIschemia Modified AlbuminAcute Coronary Syndrome

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Dartmouth Medical Center

Lebanon, New Hampshire, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University

Nashville, Tennessee, United States

Location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21835288DERIVED

MeSH Terms

Conditions

Myocardial IschemiaAngina, UnstableChest PainAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James L Januzzi, M.D.

    Massachusetts General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2006

First Posted

July 25, 2006

Study Start

September 1, 2006

Study Completion

December 1, 2007

Last Updated

May 12, 2009

Record last verified: 2009-05

Locations

US(4)CA(1)