Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between Bi-, Three-dimensional and Cardiac Magnetic Resonance

Acute Myocardial Infarction Clinical Trial

Official title:

Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between bi-, Three-dimensional and Cardiac Magnetic Resonance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623272
• Other study ID #: 2007 28
• Secondary ID: 2007-A01081-52
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: August 21, 2015
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: June 2008
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Other:
• compare measurements of left ventricular volumes and LVEF (by Cardiac Magnetic Resonance and Echocardiography)
To 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.

Locations

Country	Name	City	State
France	Timone's hospital	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 MONTHS	No