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
  Purpose

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.


Condition
Myocardial Infarction
Left Ventricular Systolic Dysfunction
Anterior Akinesis
Apical Akinesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Systolic Function Recuperation Assessed by Echocardiography

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 42
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Echocardiography 1 month
Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086124

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Paul Farand
Investigators
Principal Investigator: Paul Farand, md Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Paul Farand, MD, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01086124     History of Changes
Other Study ID Numbers: 10-010
Study First Received: March 11, 2010
Last Updated: July 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
echocardiography
ST elevation myocardial infarction
Heart failure
Coronary artery disease
Cardiovascular diseases

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ventricular Dysfunction, Left
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ventricular Dysfunction

ClinicalTrials.gov processed this record on April 15, 2014