Objective Systolic Function Recuperation Assessed by Echocardiography (ROSE)

July 3, 2013 updated by: Paul Farand
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Echocardiography 1 month
Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month post myocardial infarction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month post myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Farand

Investigators

  • Principal Investigator: Paul Farand, md, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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