Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias (SMASH 1)
2. juni 2020 oppdatert av: Torbjorn Omland, University Hospital, Akershus
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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
504
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Lørenskog, Norge, 1478
- Akershus University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients treated with an ICD.
Inclusion from outpatient clinic.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
Tidsramme: 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
|
Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
All-cause mortality
Tidsramme: 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
Tidsramme: 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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Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality
Tidsramme: 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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Heart failure hospitalization
Tidsramme: 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
Tidsramme: 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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|
Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD
Tidsramme: 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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New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.)
Tidsramme: 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.
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Torbjørn Omland, MD,PhD, MPH, Professor of Medicine
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2016
Primær fullføring (Faktiske)
31. desember 2019
Studiet fullført (Forventet)
1. desember 2050
Datoer for studieregistrering
Først innsendt
1. juli 2016
Først innsendt som oppfylte QC-kriteriene
11. august 2016
Først lagt ut (Anslag)
12. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2015/2080
Plan for individuelle deltakerdata (IPD)
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Ubestemt
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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