Skip to main content
OpenTrials
Completed

NCT Number: NCT00487812

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging

Procedure

All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)

Primary outcomes

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

    Time frame: at 6-months follow-up

Secondary outcomes

  1. Development of overt heart failure

    Time frame: development of overt heart failure

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Jun 19, 2007
Registry last updated
Oct 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.