Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) (VISION)

20. april 2018 oppdatert av: McMaster University

Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study

The investigators' study has 4 primary objectives. Among patients undergoing noncardiac surgery the investigators will determine: (1) the incidence of major perioperative vascular events; (2) the optimal clinical model to predict major perioperative vascular events; (3) the proportion of patients with perioperative myocardial infarctions that may go undetected without perioperative troponin monitoring; and (4) the relationship between postoperative troponin measurements and the 1 year risk of vascular death.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

The increase in elderly patients undergoing surgery, the change in the invasiveness of some surgical interventions, limitations in the methodology and generalizability of previous research, and the VISION Pilot Study results highlight uncertainty about the current incidence of major vascular events and the optimal clinical risk estimation model to predict these events in patients undergoing noncardiac surgery. There is promising but inconclusive preliminary evidence that troponin measurements after surgery may allow physicians to avoid missing perioperative myocardial infarctions and may predict mortality and major vascular events in the first year following surgery. These considerations provide the impetus for the large, adequately powered, multicentre, international, prospective cohort study.

We will determine the incidence of major vascular events, the optimal clinical model to predict major perioperative vascular events, and the extent to which troponin measurements post surgery can identify myocardial infarctions that are likely to go unrecognized and predict vascular death at 1 year. We call this study the Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study.

The VISION Study is a prospective cohort study of 40,000 patients who are > 45 years of age, undergoing noncardiac surgery requiring overnight hospital admission, and receiving a general or regional anesthetic. Hospitals (including both university and non-university hospitals) in several countries around the world will recruit patients, over a 2 year period. Study personnel will evaluate patients prior to surgery, follow patients throughout their hospitalization, and contact patients at 30 days and 1 year after surgery. All patients will have troponin T measured post surgery and on the first, second, and third days after surgery. Outcome adjudicators will adjudicate all major vascular events without knowledge of a patient's vascular risk factors.

We will also determine if there are associations between any preoperative or postoperative medications and major perioperative vascular events. We will also determine if there are associations between any medications started after a major perioperative vascular event and vascular mortality 1 year after surgery. We will evaluate the 1 year risk of stroke in patients who do and do not develop atrial fibrillation after surgery and if there is an association with antiplatelet or warfarin therapy. We will measure N-terminal prohormone brain natriuretic peptide (NT-proBNP) in 8,000 - 10,000 patients prior to surgery and determine if NT-proBNP is an independent predictor of major perioperative vascular events. We will determine the incidence of perioperative new acute renal failure requiring dialysis and pneumonia and develop models to predict these events.

Studietype

Observasjonsmessig

Registrering (Faktiske)

40060

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Brasil
- SP
  - São Paulo, SP, Brasil, 04005-000
    - Instituto de Ensino e Pesquisa do Hospital do Coração (IEP-HCor)
Canada
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Health Science Centre, McMaster University
  - Hamilton, Ontario, Canada, L8N 4A6
    - Saint Joseph's Healthcare
Colombia
- Santander
  - Bucaramanga, Santander, Colombia
    - Universidad Autónoma de Bucaramanga
India
- - Bangalore, India
    - St. John's Medical College
Kina
- - Hong-Kong, Kina
    - Prince of Wales Hospital
Malaysia
- - Kuala Lumpur, Malaysia, 50603
    - Hospital: University Malaya
Spania
- - Barcelona, Spania, 08041
    - Centro Cochrane Iberoamericano. Hospital de la Santa Creu i Sant Pau

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

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All patients who undergo noncardiac surgery who are at least 45 years of age and receive a general or regional anesthetic from University and Non-University Hospitals.

Beskrivelse

Inclusion Criteria:

All patients who undergo noncardiac surgery are eligible if they are > 45 years of age and receive a general or regional anesthetic (i.e., plexus block, spinal, or epidural).

Exclusion Criteria:

We will exclude patients undergoing noncardiac surgery who do not require at least an overnight hospital admission after surgery or who only receive infiltrative (i.e., local) or topical anesthesia.
We will also exclude patients previously enrolled in the VISION Study and patients who do not consent to participate.

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) Tidsramme: 30 days post surgery.	30 days post surgery.

Sekundære resultatmål

Resultatmål	Tidsramme
For our second objective (i.e., the optimal clinical model to predict major perioperative vascular events) our primary and only outcome is major vascular events. Tidsramme: 30 days after surgery.	30 days after surgery.
For our third objective (i.e., proportion of patients with perioperative myocardial infarctions that may go undetected without perioperative troponin monitoring) our outcome is myocardial infarction that probably or possibly would have gone undetected Tidsramme: 30 days after surgery.	30 days after surgery.
For our fourth objective (i.e., the relationship between postoperative troponin measurements and the 1 year risk of vascular death) our outcomes are vascular death, and major vascular events (i.e., vascular death, MI, cardiac arrest, stroke) Tidsramme: 1 year after surgery.	1 year after surgery.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

McMaster University

Samarbeidspartnere

Hamilton Health Sciences Corporation

Heart and Stroke Foundation of Ontario

Population Health Research Institute

Roche Diagnostic Ltd.

Ministry of Research, Innovation and Science, Ontario

CLARITY Group

Etterforskere

Hovedetterforsker: Philip J Devereaux, MD, PhD, McMaster University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. august 2007

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)