ROSE: Objective Systolic Function Recuperation Assessed by Echocardiography

Sponsor
Paul Farand (Other)
Overall Status
Completed
CT.gov ID
NCT01086124
Collaborator
(none)
42
1
33.1
1.3

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Objective Systolic Function Recuperation Assessed by Echocardiography
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Echocardiography 1 month

Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction

Outcome Measures

Primary Outcome Measures

  1. Left ventricular ejection fraction recuperation 1 month post myocardial infarction [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

Secondary Outcome Measures

  1. Anterior and apical akinesis recuperation 1 month post myocardial infarction [1 month post myocardial infarction]

    Anterior and apical akinesis recuperation 1 month post myocardial infarction as compared with 3 months post myocardial infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4

Sponsors and Collaborators

  • Paul Farand

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul Farand, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01086124
Other Study ID Numbers:
  • 10-010
First Posted:
Mar 12, 2010
Last Update Posted:
Jul 8, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Paul Farand, MD, Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2013