CCTA to Optimize the Diagnostic Yield of Invasive Angiography (CarDIA)
14. mars 2022 oppdatert av: Hamilton Health Sciences Corporation
Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
This study aims to reduce patient risk and costs to the healthcare system by improving the diagnostic yield of invasive coronary angiography through existing triage processes to improve risk stratification using Coronary Computed Tomographic Angiography (CCTA) as a first step in low risk patients.
All low-risk patients referred for invasive coronary angiography will be potentially eligible for CCTA instead of invasive angiography as a first-line diagnostic test.
All CCTAs will be read by both a level 3-trained cardiologist and a radiologist.
The results of the CCTA, coupled with evidence-based management recommendations will be sent to the referring physician and an invasive angiogram will be arranged by the HIU triage, only when clearly indicated
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
186
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
-
-
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 til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
All eligible low-risk patients referred for invasive angiography will be recruited from the two interventional sites (approximately 240) via centralized triage process.
Patients treated before the intervention implementation will be the control group (approximately 480).
Beskrivelse
Inclusion Criteria:
- Non urgent outpatient referral
- Canadian Cardiovascular Society class I or II
- Indication for invasive angiogram includes: Rule out Coronary Artery Disease (CAD) and Cardiomyopathy
Exclusion Criteria:
- Age <18 years old, Men >65 years old or women >75 years old
- Patient refusal to provide verbal consent for CCTA at time of triage contact or unable to provide informed consent
- Referring physician refusal for their eligible patients to be approached for the CarDIA study
- Any prior CCTA
- Atrial Fibrillation
- Creatinine > 150 mmol/L
- Diabetes mellitus
- High risk Exercise Stress Test or Functional Imaging
- Known severe valvular disease being considered for valve surgery
Any known CAD
- Prior Acute Coronary Syndrome (ACS)
- Prior Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG)
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 |
Intervensjon / Behandling |
|---|---|
|
Intervention Group
All low-risk patients referred for invasive coronary angiography through the Hamilton General Hospital's Heart Investigation Unit Triage will be potentially eligible to receive the intervention over a 12-month period.
The intervention will include risk stratification with CCTA at HHS and NHS as an alternative to upfront invasive angiography.
|
All low-risk patients referred for invasive coronary angiography will be potentially eligible to receive the intervention over a 12-month period.
The intervention will include risk stratification using Coronary Computed Tomographic Angiography (CCTA) at HHS and NHS as an alternative to upfront invasive angiography.
All CCTAs will be read by both a level 3-trained cardiologist and a radiologist.
The results of the CCTA, coupled with evidence-based management recommendations will be sent to the referring physician and an invasive angiogram will be arranged only when indicated as per these management recommendations
|
|
Control Group
Intervention sites will act as their own controls: outcomes of all eligible patients in the 24-months prior to the implementation of the intervention will be assessed from a routinely collected health administrative database.
Eligible patients not undergoing CCTA (patient or physician refusal, or CCTA not available) will be captured and included in the control group as part of a sensitivity analysis during the intervention period
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic yield of invasive angiography
Tidsramme: Three years
|
Diagnostic yield is defined as the proportion of invasive angiograms that identify significant disease (≥70% stenosis) on a major coronary vessel (>2 mm) or > 50% stenosis in the left main)
|
Three years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quantitative assessment of angiograms avoided
Tidsramme: Three years
|
Number of angiograms avoided due to CCTA bookings
|
Three years
|
|
Deviation from management recommendations following CCTA
Tidsramme: Three years
|
Number of angiograms performed when not recommended
|
Three years
|
|
Protocol deviation as a surrogate for acceptability of the novel triage program
Tidsramme: Three years
|
Percentage of patients and physicians refusing to undergo CCTA as a first step
|
Three years
|
|
Costing of new strategy
Tidsramme: Three years
|
Cost of risk stratification of Coronary Artery Disease in low risk patients
|
Three years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jon-David Schwalm, MD,FRCPC,Msc, Hamilton Health Sciences Corporation
- Hovedetterforsker: Tej Sheth, Bsc,FRCPC,MD, Hamilton Health Sciences Corporation
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
- Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272. Erratum In: N Engl J Med. 2010 Jul 29;363(5):498.
- Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441. Erratum In: BMJ. 2016 Nov 29;355:i6420.
- Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656.
- Sheth T, Amlani S, Ellins ML, Mehta S, Velianou J, Cappelli G, Yang S, Natarajan M. Computed tomographic coronary angiographic assessment of high-risk coronary anatomy in patients with suspected coronary artery disease and intermediate pretest probability. Am Heart J. 2008 May;155(5):918-23. doi: 10.1016/j.ahj.2007.11.035. Epub 2008 Feb 19.
- Ouellette ML, Beller GA, Loffler AI, Workman VK, Bourque JM. Appropriate Referrals of Angiography Despite High Prevalence of Normal Coronary Arteries or Nonobstructive CAD. J Am Coll Cardiol. 2017 May 30;69(21):2673-2675. doi: 10.1016/j.jacc.2017.03.565. No abstract available.
- Zhang F, Wagner AK, Ross-Degnan D. Simulation-based power calculation for designing interrupted time series analyses of health policy interventions. J Clin Epidemiol. 2011 Nov;64(11):1252-61. doi: 10.1016/j.jclinepi.2011.02.007.
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)
9. juli 2018
Primær fullføring (Faktiske)
28. februar 2020
Studiet fullført (Faktiske)
1. mars 2022
Datoer for studieregistrering
Først innsendt
30. mai 2018
Først innsendt som oppfylte QC-kriteriene
30. mai 2018
Først lagt ut (Faktiske)
12. juni 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4697
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .