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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487812
• Other study ID #: CHU63-0017
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: October 6, 2008
• Start date: December 2004
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Ventricular Remodeling

Intervention

Procedure:
• Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of left ventricular remodelling at 6-month follow-up		at 6-months follow-up	Yes
Secondary	Development of overt heart failure		development of overt heart failure	Yes