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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00623272
First received: February 14, 2008
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

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


Condition Intervention
Acute Myocardial Infarction
 Other: compare measurements of left ventricular volumes and LVEF (by Cardiac Magnetic Resonance and Echocardiography)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between bi-, Three-Dimensional and Cardiac Magnetic Resonance

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623272

Locations
France
Timone's hospital
Marseille, France, 13
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: franck THUNY, MD Assistance Publique des Hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance publique hopitaux de marseille, Direction de la recherche
ClinicalTrials.gov Identifier: NCT00623272     History of Changes
Other Study ID Numbers: 2007 28, 2007-A01081-52
Study First Received: February 14, 2008
Last Updated: June 13, 2008
Health Authority: France: Ministry of Health
France: Institutional Ethical Committee

Keywords provided by Assistance Publique Hopitaux De Marseille:
The assessment of left ventricular ejection fraction (LVEF)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013