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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01122069
Other study ID # MCE-NSTEMI
Secondary ID REK237.07
Status Completed
Phase N/A
First received May 10, 2010
Last updated May 11, 2010
Start date March 2008
Est. completion date July 2009

Study information

Verified date December 2007
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Committee for Medical and Health Research Ethics, Health Region West.
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- acute non-ST elevation myocardial infarction

Exclusion Criteria:

- hemodynamic unstable

- mechanical prosthetic heart valve

- severly reduced pulmonary function

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Norway Department of Heart Disease, Haukeland University Hospital Bergen

Sponsors (2)

Lead Sponsor Collaborator
University of Bergen Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

See also
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Recruiting NCT01013038 - Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study Phase 4