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Clinical Trials/NCT00487812
NCT00487812
Completed
Not Applicable

Prediction of Left Ventricular Remodelling in Patients Treated by Angioplasty in the Acute of Phase of a First Myocardial Infarction by Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT

University Hospital, Clermont-Ferrand1 site in 1 country50 target enrollmentDecember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Heart Disease
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
50
Locations
1
Primary Endpoint
Development of left ventricular remodelling at 6-month follow-up
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. It is important to predict the occurrence of this phenomenon in the early phase after MI for the selection of patients who could eventually benefit from new therapeutic approach as for example cell replacement therapy. It has been advocated that stem cells coronary injections should be performed between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left ventricular remodelling and serve as a method to screen patients who could benefit from cell replacement therapy.

Detailed Description

All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day) and at 6-month follow-up. Left ventricular remodelling will be defined as an end-diastolic volume increase of \>20% between the two exams. A low dose dobutamine gated Tc-99m-mibi SPECT will be also performed on 5th-6th day. Differences in the infarct size and severity as well as the residual inotrope reserve in the infarct area are expected between groups with and without remodelling.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
September 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand

Eligibility Criteria

Inclusion Criteria

  • Acute myocardial infarction,
  • Successful coronary angioplasty in the acute phase,
  • Absence of heart failure in the acute phase

Exclusion Criteria

  • acute heart failure in the acute phase
  • severe ventricular arrhythmias
  • contra indications for MRI imaging

Outcomes

Primary Outcomes

Development of left ventricular remodelling at 6-month follow-up

Time Frame: at 6-months follow-up

Secondary Outcomes

  • Development of overt heart failure(development of overt heart failure)

Study Sites (1)

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