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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Disease; Ventricular Arrhythmias; Implantable Defibrillator User; Biological 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.

• Study Type: Observational
• Enrollment (Actual): 504

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway, 1478
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an ICD. Inclusion from outpatient clinic.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: University of Oslo; Helse Stavanger HF
• Investigators: Principal Investigator: Torbjørn Omland, MD,PhD, MPH, Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 1, 2050

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Ventricular Arrhythmias; ICD; Biological markers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 2015/2080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No