Clinical trial NCT00623272: Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between Bi-, Three-dimensional and Cardiac Magnetic Resonance
Official title: Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between bi-, Three-dimensional and Cardiac Magnetic Resonance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: The assessment of left ventricular ejection fraction (LVEF)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction

Detailed description: The assessment of left ventricular ejection fraction (LVEF) is a critical step after a myocardial infarction because it determines the prognosis and the therapeutic management (indication of implantable cardioverter-defibrillators). Three-dimensional echocardiography (3DE) and cardiac magnetic resonance (CMR) are accurate and reproducible techniques to quantify left ventricular volumes and LVEF. However, all the large randomized trials which evaluated the role of the implantable cardioverter-defibrillators (ICD) on survival in primary prevention were based on LVEF values obtained by older techniques like bi-dimensional echocardiography (2DE), angiography or radionuclide scanning. From now, no study has compared the measurements of left ventricular volumes and LVEF obtained by further current techniques after an acute myocardial infarction (AMI) particularly after 1 month when ICD could be indicated.

Eligibility criteria: Inclusion Criteria:

* All the patients presenting a first ischemic clinical episode for at least 30 minutes, associated with one known gap will be included in a forward-looking and consecutive way, of at least 0.1mV in at least two peripheral diversions of the same territory or of at least 0.2 mV in at least two precordial diversions of the same territory
* An initial FEVG (measured by echocardiography or ventricular angiography in the daytime of the admittance)

Exclusion Criteria:

* Age \< 18 years
* Antecedents of IDM
* Contraindications in the MRI (claustrophobia, stimulating and defibrillators heart patient implantable, metal intraocular brightness, allergy in the gadolinium, the severe renal insufficiency with clearance in the creatinine ≤30 mL/min)
* Fibrillation little finger
* Pregnancy.

Primary outcomes:
measure: compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction.
timeFrame: 3 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Timone's hospital
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: franck THUNY, MD
role: PRINCIPAL_INVESTIGATOR
References: