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Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias

Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias: A Multicenter, Observational Trial

NCT02864771•University Hospital, Akershus

View on ClinicalTrials.gov

Summary

The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.

Detailed Description

This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients ≥ 18 years old
•Current treatment with an ICD
•Signed written informed consent before study commencement

Exclusion Criteria

•Participation in other interventional clinical trial or previously included in the current study
•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

Locations (1)

Akershus University Hospital

Lørenskog, Norway

Key Dates

Start Date

August 1, 2016

Primary Completion Date

December 31, 2019

Completion Date

December 1, 2050

Last Updated

June 4, 2020

Enrollment

504

ACTUAL participants

Conditions

Ventricular ArrhythmiasImplantable Defibrillator UserBiological MarkersHeart Disease

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

NCT06835491

Ventricular Arrhythmias and Cardiac Arrest

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RECRUITINGNA

Self-Management Interventions After an ICD Shock

NCT06037785

Implantable Defibrillator UserStress Reaction+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias

Inclusion Criteria

Exclusion Criteria

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

Self-Management Interventions After an ICD Shock

French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

Ultra High Resolution CT to Assess Role of Intramyocardial Fat and Delayed Enhancement in Ventricular Arrhythmogenesis

Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillator

Impact of Catheter Ablation of Frequent Premature Ventricular Complexes in Treating Subtle Left Cardiomyopathy