Clinical trial NCT02286908: Global Strain and Mechanical Dispersion May Predict Death and Ventricular Arrhythmias Better Than Ejection Fraction
Official title: Improved Prediction of Clinical Outcome With the Use of Global Strain and Mechanical Dispersion in Patients With Myocardial Infarction and Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricular Function Systolic Dysfunction
Keywords: Ejection fraction, Global Strain, Mechanical dispersion
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2014-11-10
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with myocardial infarction, heart failure and patients planned for primary prophylactic ICD. Echocardiography is performed at inclusion. Comparism of the ability of left ventricular ejection fraction, global strain and mechanical dispersion to predict clinical outcome in patients with these conditions.

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Ventricular arrhythmia and death after acute myocardial infarction or heart failure.
timeFrame: 5 years or more
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Vseobecna fakultni nemocnice Praha/ Prague General hospital
city: Arendal
country: Norway
facility: Sørlandet sykehus HF
state: Agder
city: Drammen
country: Norway
facility: Vestre Viken HF
city: Kristiansand
country: Norway
facility: Sørlandet sykehus Kristiansand
city: Oslo
country: Norway
facility: Oslo university hospital
city: Skien
country: Norway
facility: Sykehuset Telemark HF
city: Stavanger
country: Norway
facility: Stavanger universitetssjukehus
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord Norge, Tromsø
Study officials:
affiliation: Oslo University Hospital
name: Thor Edvardsen, MD, PHD
role: STUDY_DIRECTOR
References: