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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02864771
Other study ID # 2015/2080
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 2016
Est. completion date December 2050

Study information

Verified date June 2020
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 504
Est. completion date December 2050
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Norway Akershus University Hospital Lørenskog

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Akershus Helse Stavanger HF, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 All-cause mortality Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Secondary Cardiovascular mortality Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Secondary 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.
Secondary Heart failure hospitalization Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Secondary 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.
Secondary Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) 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 New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.) Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Secondary Episodes of ventricular- or supra-ventricular arrhythmias (specified above) 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.
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