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Objective Systolic Function Recuperation Assessed by Echocardiography (ROSE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Universitaire de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01086124
First received: March 11, 2010
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Universitaire 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


Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
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

Contacts
Contact: Emilie Belley-Côté, md 819 346-1110 emilie-prudence.belley-cote@usherbrooke.ca
Contact: Paul Farand, md 819 346-1110 paul.farand@usherbrooke.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Emilie Belley-Côté, md     819 346-1110     emilie-prudence.belley-cote@usherbrooke.ca    
Sponsors and Collaborators
Universitaire de Sherbrooke
Investigators
Principal Investigator: Paul Farand, md Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Dr Paul Farand, CHUS
ClinicalTrials.gov Identifier: NCT01086124     History of Changes
Other Study ID Numbers: 10-010
Study First Received: March 11, 2010
Last Updated: September 13, 2010
Health Authority: Canada: Health Canada

Keywords provided by Universitaire 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 May 22, 2013