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

NCT ID: NCT02286908

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Left Ventricular Function Systolic Dysfunction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thor Edvardsen

Professor, Chief department of Cardiology Oslo university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thor Edvardsen, MD, PHD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Vseobecna fakultni nemocnice Praha/ Prague General hospital

Prague, , Czechia

Site Status RECRUITING

Sørlandet sykehus HF

Arendal, Agder, Norway

Site Status RECRUITING

Vestre Viken HF

Drammen, , Norway

Site Status RECRUITING

Sørlandet sykehus Kristiansand

Kristiansand, , Norway

Site Status RECRUITING

Oslo university hospital

Oslo, , Norway

Site Status RECRUITING

Sykehuset Telemark HF

Skien, , Norway

Site Status RECRUITING

Stavanger universitetssjukehus

Stavanger, , Norway

Site Status RECRUITING

Universitetssykehuset Nord Norge, Tromsø

Tromsø, , Norway

Site Status RECRUITING

Countries

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Czechia Norway

Central Contacts

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Thor Edvardsen, MD, PHD

Role: CONTACT

Harald Brunvand, MD, PHD

Role: CONTACT

Facility Contacts

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Josef Marek

Role: primary

Daniela Melichova, MD

Role: primary

Thuy Mi Nguyen, MD

Role: backup

Erik Gjertsen

Role: primary

Tor Olav Isaksen

Role: primary

Thor Edvardsen, MD, PhD

Role: primary

Jacob Thalamus

Role: primary

Dennis Nilsen

Role: primary

Pål Tande

Role: primary

Henrik Schirmer

Role: backup

Other Identifiers

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2013/573/REK sør-øst

Identifier Type: -

Identifier Source: org_study_id

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