Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time (CanPREDDICT)
27. november 2013 oppdatert av: University of British Columbia
CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months.
This observational study will analyze the demographics, clinical status, medications and blood and urine samples of these patients and study the conventional biochemical, hormonal and metabolic parameters assessing which underlying biomarkers reflect the processes involved with disease progression.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
2602
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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Alberta
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Calgary, Alberta, Canada
- Foothills Hospital
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Edmonton, Alberta, Canada
- University of Alberta
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British Columbia
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Penticton, British Columbia, Canada
- Penticton Regional Hospital
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Vancouver, British Columbia, Canada
- Vancouver General Hospital
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Vancouver, British Columbia, Canada
- BC Children's Hospital
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada
- St. Boniface Hospital
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada
- Eastern Regional Health Authority, Health Sciences Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada
- QEII Health Sciences Centre
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Sydney, Nova Scotia, Canada
- Cape Breton District Health Authority
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Ontario
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Hamilton, Ontario, Canada
- St Joseph's Hospital
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Kingston, Ontario, Canada
- Kingston General Hospital
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London, Ontario, Canada
- London Health Science Centre- Victoria Campus
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London, Ontario, Canada
- London Health Science Centre- University Campus
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Oak Ridges, Ontario, Canada
- York Central
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Ottawa, Ontario, Canada
- University of Ottawa
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Timmins, Ontario, Canada
- Timmins & District Hospital
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Toronto, Ontario, Canada
- St. Michael's Hospital
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Toronto, Ontario, Canada
- University Health Network
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Toronto, Ontario, Canada
- Sunnybrook Hospital
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Quebec
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Greenfield Park, Quebec, Canada
- Charles Le Moyne Hospital
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Montreal, Quebec, Canada
- Royal Victoria Hospital
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Montreal, Quebec, Canada
- Hopital du Sacre-Coeur
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Montréal, Quebec, Canada
- Maisonneuve-Rosemont Hopital
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Quebec City, Quebec, Canada
- CHUQ: L'Hôtel-Dieu de Québec
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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
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Nephrology Clinics across Canada
Beskrivelse
Inclusion Criteria:
- Patients currently seen by a nephrologist, or referred for evaluation of CKD
- GFR between 15-45 ml/min
- Adults 19 years (depending on age of consent in province) or older
- At pediatric sites study participants will be eligible to participate at age 15 or older
Exclusion Criteria:
- Organ transplant recipient
- Life expectancy less than 12 months
- Acute Vasculitis
- Bioimpedance sub-study exclusion criteria:
- Amputation (readings are inaccurate)
- Any battery operated or electronic implanted device (such as pacemaker or implanted defibrillator - potential electrical hazard)
- Pregnant women
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Bioimpedance sub-study cohort
Funded by a grant from Kidney Foundation of Canada, Dr. Catherine Clase initiated a bioimpedance sub-study across 7 centres and recruited n=416 within the CANPREDDICT population.
The study uses bioimpedance measurements to assess volume status to determine the multivariable relationship between baseline volume overload and subsequent cardiovascular events.
Subjects are followed at 6 months intervals for 2 years.
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Ethnic enrichment cohort
Additional recruitment initiated and funded by the Principal Investigator, Adeera Levin for enriching the ethnic representation within the Canadian cohort on South Asian and Oriental Asian was completed from Sept 2012 to June 2013, n=53.
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Original CanPreddict cohort
The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Renal Replacement Therapy
Tidsramme: 6 monthly for 3 years, annually up to 5 years
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Renal Replacement Therapy is defined as dialysis start or transplantation.
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6 monthly for 3 years, annually up to 5 years
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Cardiovascular events
Tidsramme: 6 monthly for 3 years, annually up to 5 years
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Cardiovascular events are defined as myocardial infarction, ischemic and hemorrhagic stroke, coronary revascularization, congestive heart failure, peripheral bypass and gangrenes, adjudicated by a nephrologist, cardiologist and neurologist.
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6 monthly for 3 years, annually up to 5 years
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Death
Tidsramme: 6 monthly for 3 years, annually up to 5 years
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Deaths are reported with source documentation and adjudicated for ischemic or congestive cardiovascular death, other cardiovascular death, non-cardiovascular death and unknown cause of death.
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6 monthly for 3 years, annually up to 5 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Adeera Levin, University of British Columbia
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
- Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT investigators. Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT). BMC Nephrol. 2013 Jun 11;14:121. doi: 10.1186/1471-2369-14-121.
- Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase C, Tang M, Djurdjev O. (2012). Canadian study of prediciont of death, dialysis and interim cardiovascular events: CanPREDDICT: Biomarkers improve prediction of one year outcomes in chronic kidney disease cohort. Clinical studies in CKD. Nephrology Dialysis Transplantation, 27(suppl 2), ii63-ii65.
- Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT Investigators. Biomarkers of inflammation, fibrosis, cardiac stretch and injury predict death but not renal replacement therapy at 1 year in a Canadian chronic kidney disease cohort. Nephrol Dial Transplant. 2014 May;29(5):1037-47. doi: 10.1093/ndt/gft479. Epub 2013 Dec 26.
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. juni 2008
Primær fullføring (Forventet)
1. desember 2014
Studiet fullført (Forventet)
1. desember 2014
Datoer for studieregistrering
Først innsendt
20. januar 2009
Først innsendt som oppfylte QC-kriteriene
21. januar 2009
Først lagt ut (Anslag)
22. januar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. november 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. november 2013
Sist bekreftet
1. november 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H07-02457
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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