Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias
NCT ID: NCT02864771
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
504 participants
OBSERVATIONAL
2016-08-31
2050-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
NCT05868616
Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias
NCT00562757
Arrhythmias Detection in a Real World Population
NCT02275637
NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
NCT01282918
Acute Defibrillation Study
NCT02227121
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power
No interventions assigned to this group
2
Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current treatment with an ICD
* Signed written informed consent before study commencement
Exclusion Criteria
* Patients not able to provide written informed consent
* Known or suspected, non-curable cancer,
* Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (ALS)
* Patients unwilling or unable to comply with the protocol
* History of non-compliance to medical management and patients who are considered potentially unreliable by the Investigator
* History or evidence of alcohol or drug abuse with the last 12 months that may influence the participation of the patient in the study, as assessed by the Investigator during the screening phase
* Any surgical or medical condition, which in the option of the Investigator, will impair the ability of the patient to participate in the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helse Stavanger HF
OTHER_GOV
University of Oslo
OTHER
University Hospital, Akershus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Torbjorn Omland
Professor in Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Torbjørn Omland, MD,PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akershus University Hospital
Lørenskog, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015/2080
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.