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Contrast Echocardiography in Non-ST Elevation Myocardial Infarction

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT01122069
Collaborator
Haukeland University Hospital (Other)
110
Enrollment
1
Location
16
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are initially medically treated and recommended coronary angiography within 48-72 hours.

Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction (TIMI) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. However, new research has suggested that TIMI risk score may not always identify patients with severe angiographic disease.

The purpose of this study was to assess if contrast echocardiography could be used to identify NSTEMI patients with angiographically severe disease independent of their TIMI risk score.

Condition or Disease Intervention/Treatment Phase
  • Other: Perflutren Lipid Microsphere ultrasound contrast

Study Design

Study Type:
Observational
Actual Enrollment :
110 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Contrast Echocardiography in Assessment of Myocardial Perfusion in Patients With Non-ST Elevation Myocardial Infarction
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Contrast echocardiography

110 patients with acute non-ST elevation myocardial infarct were examined with contrast echocardiography prior to coronary angiography.

Other: Perflutren Lipid Microsphere ultrasound contrast
Perflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus
Other Names:
  • Luminity

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • acute non-ST elevation myocardial infarction
      Exclusion Criteria:

      • hemodynamic unstable

      • mechanical prosthetic heart valve

      • severly reduced pulmonary function

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Heart Disease, Haukeland University Hospital Bergen Norway

      Sponsors and Collaborators

      • University of Bergen
      • Haukeland University Hospital

      Investigators

      • Principal Investigator: Mai Tone Lønnebakken, MD, University of Bergen, Bergen, Norway

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01122069
      Other Study ID Numbers:
      • MCE-NSTEMI
      • REK237.07
      First Posted:
      May 12, 2010
      Last Update Posted:
      May 12, 2010
      Last Verified:
      Dec 1, 2007
      Additional relevant MeSH terms:
      Myocardial Infarction
      Non-ST Elevated Myocardial Infarction
      Infarction

      Study Results

      No Results Posted as of May 12, 2010