- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02864771
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
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Lørenskog, Norge, 1478
- Akershus University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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1
Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power
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2
Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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).
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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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.
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
All-cause mortality
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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Cardiovascular mortality
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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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
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
Heart failure hospitalization
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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The combination of cardiovascular mortality and heart failure hospitalizations
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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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.)
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
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.
Tidsram: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Torbjørn Omland, MD,PhD, MPH, Professor of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2015/2080
Plan för individuella deltagardata (IPD)
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