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

NCT ID: NCT00623272

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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franck THUNY, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hôpitaux de Marseille

Locations

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Timone's hospital

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2007-A01081-52

Identifier Type: -

Identifier Source: secondary_id

2007 28

Identifier Type: -

Identifier Source: org_study_id

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