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Active, Not Recruiting

NCT Number: NCT02864771

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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

    Registered from the monitoring function of the ICD

Secondary outcomes

  1. All-cause mortality

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

  2. Cardiovascular mortality

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

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

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

  4. Heart failure hospitalization

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

  5. The combination of cardiovascular mortality and heart failure hospitalizations

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

  6. Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD

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

  7. New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.)

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

  8. Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Helse Stavanger HF
  • University of Oslo

Registry information

Official study title

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

Acronym: SMASH 1

Important dates

Study start
2016
Primary completion
2019
Study completion
2050
First posted
Aug 12, 2016
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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