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Objective Systolic Function Recuperation Assessed by Echocardiography (ROSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01086124
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Paul Farand, Université de Sherbrooke

Tracking Information
First Submitted Date March 11, 2010
First Posted Date March 12, 2010
Last Update Posted Date July 8, 2013
Study Start Date March 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2010)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 11, 2010)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Objective Systolic Function Recuperation Assessed by Echocardiography
Official Title Objective Systolic Function Recuperation Assessed by Echocardiography
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients presenting to teaching hospital or sent from community hopitals to teaching hospital for primary PCI
Condition
  • Myocardial Infarction
  • Left Ventricular Systolic Dysfunction
  • Anterior Akinesis
  • Apical Akinesis
Intervention Not Provided
Study Groups/Cohorts Echocardiography 1 month
Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 3, 2013)
42
Original Estimated Enrollment
 (submitted: March 11, 2010)
50
Actual Study Completion Date December 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01086124
Other Study ID Numbers 10-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Paul Farand, Université de Sherbrooke
Study Sponsor Paul Farand
Collaborators Not Provided
Investigators
Principal Investigator: Paul Farand, md Centre de recherche du Centre hospitalier universitaire de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date July 2013