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

Primary Purpose

Ischemic Heart Disease, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Acute myocardial infarction, left ventricular remodelling, SPECT imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Development of overt heart failure

Full Information

First Posted
June 18, 2007
Last Updated
October 6, 2008
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00487812
Brief Title
Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Myocardial Infarction
Keywords
Acute myocardial infarction, left ventricular remodelling, SPECT imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging
Intervention Description
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)
Primary Outcome Measure Information:
Title
Development of left ventricular remodelling at 6-month follow-up
Time Frame
at 6-months follow-up
Secondary Outcome Measure Information:
Title
Development of overt heart failure
Time Frame
development of overt heart failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lipiecki Janusz, Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19479315
Citation
Ernande L, Cachin F, Chabrot P, Durel N, Morand D, Boyer L, Maublant J, Lipiecki J. Rest and low-dose dobutamine Tc-99m-mibi gated-SPECT for early prediction of left ventricular remodeling after a first reperfused myocardial infarction. J Nucl Cardiol. 2009 Jul-Aug;16(4):597-604. doi: 10.1007/s12350-009-9098-5. Epub 2009 May 29.
Results Reference
derived

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

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