Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI

Not Applicable

Completed

• Conditions: Myocardial Infarction; Ischemic Heart Disease

• Registration Number: NCT00487812
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-08
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-18
• Study First Posted: 2007-06-19
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-06
• Last Update Posted: 2008-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Development of left ventricular remodelling at 6-month follow-up	at 6-months follow-up

Secondary Outcome Measures

Name	Time	Method
Development of overt heart failure	development of overt heart failure

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France