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OpenTrials
Completed

NCT Number: NCT01086124

Objective Systolic Function Recuperation Assessed by Echocardiography

The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Older than 18 years old
  • ST elevation myocardial infarction treated with primary PCI
  • Anterior or apical akinesis and left ventricular ejection fraction ≤ 45% on early echocardiography (48hours - 7 days post myocardial infarction)
  • Initial ECG showing at least 1 mm ST elevation in 2 leads corresponding to the same vascular territory

Exclusion criteria

  • Known left ventricular systolic dysfunction before myocardial infarction
  • Left bundle branch block
  • Vital prognosis less than 6 months
  • Cardiogenic shock
  • Rescue PCI
  • Sub-optimal echocardiographic imaging (contrast use is allowed)
  • Significant valvular heart disease (moderate or severe)
  • Surgical revascularization
  • Pregnancy or breastfeeding
  • Incapacity to provide informed consent

Treatment and study plan

Primary outcomes

  1. Left ventricular ejection fraction recuperation 1 month post myocardial infarction

    Time frame: 1 month post myocardial infarction

    Left ventricular ejection fraction recuperation 1 month post myocardial infarction as compared with the left ejection fraction 3 months post myocardial infarction

Secondary outcomes

  1. Anterior and apical akinesis recuperation 1 month post myocardial infarction

    Time frame: 1 month post myocardial infarction

    Anterior and apical akinesis recuperation 1 month post myocardial infarction as compared with 3 months post myocardial infarction

Sponsors and collaborators

Lead sponsor

Paul Farand

Other

Registry information

Acronym: ROSE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2010
Registry last updated
Jul 8, 2013

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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