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

Heart Disease Clinical Trial

— SMASH 1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02864771
• Other study ID #: 2015/2080
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Biological Markers
• Heart Disease
• Heart Diseases
• Implantable Defibrillator User
• Ventricular Arrhythmias

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.