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Objective Systolic Function Recuperation Assessed by Echocardiography (ROSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Farand, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01086124
First received: March 11, 2010
Last updated: July 3, 2013
Last verified: July 2013

March 11, 2010
July 3, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
Left ventricular ejection fraction recuperation 1 month post myocardial infarction [ Time Frame: 1 month post myocardial infarction ] [ Designated as safety issue: No ]
Left ventricular ejection fraction recuperation 1 month post myocardial infarction as compared with the left ejection fraction 3 months post myocardial infarction
Same as current
Complete list of historical versions of study NCT01086124 on ClinicalTrials.gov Archive Site
Anterior and apical akinesis recuperation 1 month post myocardial infarction [ Time Frame: 1 month post myocardial infarction ] [ Designated as safety issue: No ]
Anterior and apical akinesis recuperation 1 month post myocardial infarction as compared with 3 months post myocardial infarction
Same as current
Not Provided
Not Provided
 
Objective Systolic Function Recuperation Assessed by Echocardiography
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients presenting to teaching hospital or sent from community hopitals to teaching hospital for primary PCI

  • Myocardial Infarction
  • Left Ventricular Systolic Dysfunction
  • Anterior Akinesis
  • Apical Akinesis
Not Provided
Echocardiography 1 month
Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01086124
10-010
No
Paul Farand, Universitaire de Sherbrooke
Paul Farand
Not Provided
Principal Investigator: Paul Farand, md Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP