Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias (SMASH 1)

University Hospital, Akershus

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT02864771

2015/2080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

504 participants in 2 patient groups

1

Description:

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

2

Description:

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