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OpenTrials
Completed

NCT Number: NCT00623272

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Timone's hospital

Marseille, 13, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

compare measurements of left ventricular volumes and LVEF (by Cardiac Magnetic Resonance and Echocardiography)

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2008
Registry last updated
Aug 24, 2015

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.

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