Objective Systolic Function Recuperation Assessed by Echocardiography

Myocardial Infarction Clinical Trial

— ROSE  

Official title:

Objective Systolic Function Recuperation Assessed by Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086124
• Other study ID #: 10-010
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: July 3, 2013
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anterior Akinesis
• Apical Akinesis
• Infarction
• Left Ventricular Systolic Dysfunction
• Myocardial Infarction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Paul Farand

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction recuperation 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	No
Secondary	Anterior and apical akinesis recuperation 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	No