Global Strain and Mechanical Dispersion May Predict Death and Ventricular Arrhythmias Better Than Ejection Fraction

Left Ventricular Function Systolic Dysfunction Clinical Trial

Official title:

Improved Prediction of Clinical Outcome With the Use of Global Strain and Mechanical Dispersion in Patients With Myocardial Infarction and Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02286908
• Other study ID #: 2013/573/REK sør-øst
• Status: Recruiting
• Start date: June 2014
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: Thor Edvardsen, MD, PHD
• Email: thor.edvardsen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with myocardial infarction and heart failure regardless of cause.

Description:

1. The main aim of this study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than left ventricular ejection fraction in patients with myocardial infarction and heart failure. 2. In patients who receive internal cardioverter defibrillator(ICD) the main aim is to investigate if mechanical dispersion may predict ventricular arrhythmias better than EF. 3) No interventions,only evaluation of the measurements obtained with transthoracic echocardiography. 4) Follow up for 3 years, extended from 3 to 5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with

1. myocardial infarction

2. heart failure( defined as heart failure symptoms: reduced left ventricular function/ and or heart failure signs on chest x ray.

3. planned for primary prophylactic ICD

• over 18 years of age
• Informed consent Exclusion Criteria: -

Related Conditions & MeSH terms

• Left Ventricular Function Systolic Dysfunction
• Sprains and Strains

Locations

Country	Name	City	State
Czechia	Vseobecna fakultni nemocnice Praha/ Prague General hospital	Prague
Norway	Sørlandet sykehus HF	Arendal	Agder
Norway	Vestre Viken HF	Drammen
Norway	Sørlandet sykehus Kristiansand	Kristiansand
Norway	Oslo university hospital	Oslo
Norway	Sykehuset Telemark HF	Skien
Norway	Stavanger universitetssjukehus	Stavanger
Norway	Universitetssykehuset Nord Norge, Tromsø	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority

Countries where clinical trial is conducted

Czechia,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular arrhythmia and death after acute myocardial infarction or heart failure.	Arrhythmic events during follow-up are defined as documented sustained ventricular tachycardia, ventricular fibrillation, and SCD. Survival is assessed by medical charts if patients are within the uptake area of the hospital and by the Norwegian death registry Folkeregisteret.	5 years or more