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

NCT02864771 | Active Not Recruiting DMC

• 1 other identifier: 2015/2080
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventricular Arrhythmias; Implantable Defibrillator User; Biological Markers; Heart Disease

Keywords

Ventricular Arrhythmias; ICD; Biological markers

Outcome Measures

Primary Outcomes (1)

• Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek).

  Registered from the monitoring function of the ICD

  Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

Secondary Outcomes (8)

• All-cause mortality

  Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

• Cardiovascular mortality

  Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

• Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality

  Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

• Heart failure hospitalization

  Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

• The combination of cardiovascular mortality and heart failure hospitalizations

  Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

Study Arms (2)

1

Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power

2

Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an ICD. Inclusion from outpatient clinic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Helse Stavanger HF: collaborator
• University of Oslo: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and DNA

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Torbjørn Omland, MD,PhD, MPH

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medicine

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: December 31, 2019
• Study Completion (Estimated): December 1, 2050
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

NO (1)