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

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

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.

Study Overview

• Status: Unknown
• Conditions: Left Ventricular Function Systolic Dysfunction

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

• Study Type: Observational
• Enrollment (Anticipated): 3100

Contacts and Locations

• Study Contact: Name: Thor Edvardsen, MD, PhD; Email: thor.edvardsen@medisin.uio.no
• Study Contact Backup: Name: Harald Brunvand, MD, PHD; Email: harbrun@online.no

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Vseobecna fakultni nemocnice Praha/ Prague General hospital
    • Contact: Josef Marek; Email: jsfmarek@gmail.com
• Norway
  • Drammen, Norway, 3004
    • Recruiting
    • Vestre Viken HF
    • Contact: Erik Gjertsen
  • Kristiansand, Norway, 4604
    • Recruiting
    • Sørlandet Sykehus Kristiansand
    • Contact: Finn Tore Gjestvang
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Thor Edvardsen, MD, PhD; Email: thor.edvardsen@medisin.uio.no
    • Principal Investigator: Lars Gunnar Klæboe, MD
  • Skien, Norway, 3710
    • Recruiting
    • Sykehuset Telemark HF
    • Contact: Jacob Thalamus
  • Stavanger, Norway, 4068
    • Recruiting
    • Stavanger Universitetssjukehus
    • Contact: Dennis Nilsen
  • Tromsø, Norway, 9038
    • Recruiting
    • Universitetssykehuset Nord Norge, Tromsø
    • Contact: Pål Tande
    • Contact: Henrik Schirmer
  • Trondheim, Norway, 3250
    • Recruiting
    • St. Olavs Hospital
    • Contact: Bjørnar Grenne
  • Agder
    • Arendal, Agder, Norway, 4800
      • Recruiting
      • Sørlandet Sykehus Arendal
      • Contact: Daniela Melichova, MD; Email: daniela.melichova@sshf.no
      • Contact: Thuy Mi Nguyen, MD; Email: thuy.mi.nguyen@sshf.no
      • Principal Investigator: Daniela Melichova, MD
      • Principal Investigator: Thuy Mi Nguyen, MD
      • Principal Investigator: Ivar Mjåland Salte, MD
      • Principal Investigator: Inger Johanne Omland, MD
      • Principal Investigator: Marianne Forså, MD

Participation Criteria

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 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.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority
• Investigators: Study Director: Thor Edvardsen, MD, PHD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Ejection fraction, Global Strain, Mechanical dispersion
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: 2013/573/REK sør-øst

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided