NCT02286908

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

11.5 years

First QC Date

August 22, 2014

Last Update Submit

November 7, 2023

Conditions

Keywords

Ejection fraction, Global Strain, Mechanical dispersion

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients with
  • myocardial infarction
  • heart failure( defined as heart failure symptoms: reduced left ventricular function/ and or heart failure signs on chest x ray.
  • planned for primary prophylactic ICD
  • over 18 years of age
  • Informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Vseobecna fakultni nemocnice Praha/ Prague General hospital

Prague, Czechia

RECRUITING

Sørlandet sykehus HF

Arendal, Agder, 4800, Norway

RECRUITING

Vestre Viken HF

Drammen, 3004, Norway

RECRUITING

Sørlandet sykehus Kristiansand

Kristiansand, 4604, Norway

RECRUITING

Oslo university hospital

Oslo, Norway

RECRUITING

Sykehuset Telemark HF

Skien, 3710, Norway

RECRUITING

Stavanger universitetssjukehus

Stavanger, 4068, Norway

RECRUITING

Universitetssykehuset Nord Norge, Tromsø

Tromsø, 9038, Norway

RECRUITING

Study Officials

  • Thor Edvardsen, MD, PHD

    Oslo University Hospital

    STUDY DIRECTOR

Central Study Contacts

Thor Edvardsen, MD, PHD

CONTACT

Harald Brunvand, MD, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief department of Cardiology Oslo university hospital

Study Record Dates

First Submitted

August 22, 2014

First Posted

November 10, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations