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Trial record 1 of 1 for:    NCT02286908
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Global Strain and Mechanical Dispersion May Predict Death and Ventricular Arrhythmias Better Than Ejection Fraction

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ClinicalTrials.gov Identifier: NCT02286908
Recruitment Status : Unknown
Verified September 2020 by Thor Edvardsen, Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : November 10, 2014
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Thor Edvardsen, Oslo University Hospital

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 3100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Improved Prediction of Clinical Outcome With the Use of Global Strain and Mechanical Dispersion in Patients With Myocardial Infarction and Heart Failure
Actual Study Start Date : June 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Ventricular arrhythmia and death after acute myocardial infarction or heart failure. [ Time Frame: 3 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:

-

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286908


Contacts
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Contact: Thor Edvardsen, MD, PHD thor.edvardsen@medisin.uio.no
Contact: Harald Brunvand, MD, PHD harbrun@online.no

Locations
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Czechia
Vseobecna fakultni nemocnice Praha/ Prague General hospital Recruiting
Prague, Czechia
Contact: Josef Marek       jsfmarek@gmail.com   
Norway
Sørlandet sykehus Arendal Recruiting
Arendal, Agder, Norway, 4800
Contact: Daniela Melichova, MD       daniela.melichova@sshf.no   
Contact: Thuy Mi Nguyen, MD       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         
Vestre Viken HF Recruiting
Drammen, Norway, 3004
Contact: Erik Gjertsen         
Sørlandet sykehus Kristiansand Recruiting
Kristiansand, Norway, 4604
Contact: Finn Tore Gjestvang         
Oslo university hospital Recruiting
Oslo, Norway
Contact: Thor Edvardsen, MD, PhD       thor.edvardsen@medisin.uio.no   
Principal Investigator: Lars Gunnar Klæboe, MD         
Sykehuset Telemark HF Recruiting
Skien, Norway, 3710
Contact: Jacob Thalamus         
Stavanger universitetssjukehus Recruiting
Stavanger, Norway, 4068
Contact: Dennis Nilsen         
Universitetssykehuset Nord Norge, Tromsø Recruiting
Tromsø, Norway, 9038
Contact: Pål Tande         
Contact: Henrik Schirmer         
St. Olavs Hospital Recruiting
Trondheim, Norway, 3250
Contact: Bjørnar Grenne         
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
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Study Director: Thor Edvardsen, MD, PHD Oslo University Hospital
More Information
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Responsible Party: Thor Edvardsen, Professor, Chief department of Cardiology Oslo university hospital, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02286908    
Other Study ID Numbers: 2013/573/REK sør-øst
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Thor Edvardsen, Oslo University Hospital:
Ejection fraction, Global Strain, Mechanical dispersion
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries