Utility of a smartphone application in assessing palmar circulation prior to radial artery harvesting for coronary artery bypass grafting: rationale and design of the randomised CAPITAL iRADIAL-CABG trial.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
08 04 2022
Historique:
entrez: 9 4 2022
pubmed: 10 4 2022
medline: 13 4 2022
Statut: epublish

Résumé

There is emerging evidence supporting the use of the radial artery (RA) as a preferred secondary conduit for coronary artery bypass grafting (CABG) as it is associated with higher rates of graft patency at 5 years when compared with saphenous vein grafts (SVG). The modified Allen's test (MAT) is traditionally regarded as the standard of care in the assessment of ulnar artery (UA) patency prior to RA harvesting. Unfortunately, due to high false-positive rates, a substantial number of pre-CABG patients are found to have an abnormal MAT despite normal UA patency, resulting in inappropriate exclusion from RA harvesting. The SVG is generally used in its place when this occurs, resulting in potentially lower rates of long-term graft patency. The CAPITAL iRADIAL-CABG trial is currently enrolling participants 18 years of age or older undergoing CABG for whom the treating physician is considering the use of an RA conduit. Eligible patients will be randomised in a 1:1 fashion to MAT or smartphone-based photoplethysmography application assessment to assess collateral palmar circulation prior to RA harvesting. The primary outcome of the trial is the use of the RA as a conduit during CABG. The primary safety outcome is postoperative palmar ischaemia as determined by clinical assessment or requirement of vascular intervention. Secondary outcomes include vascular complications, early graft failure, need for rescue percutaneous coronary intervention during the index hospitalisation and a composite cardiovascular outcome of myocardial infarction, stroke and cardiovascular death prior to discharge from hospital. A total of 236 participants are planned to be recruited. The study was approved by the Ottawa Heart Science Network Research Ethics Board (approval number 20180865-01H). The study results will be disseminated via conference presentations and peer-reviewed publications. NCT03810729.

Identifiants

pubmed: 35396289
pii: bmjopen-2021-055580
doi: 10.1136/bmjopen-2021-055580
pmc: PMC8995949
doi:

Banques de données

ClinicalTrials.gov
['NCT03810729']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e055580

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Cheng Yee Goh (CY)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Simon Parlow (S)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Pietro Di Santo (P)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.

Trevor Simard (T)

Department of Cardiovascular Diseases, Mayo Clinic School of Medicine, Rochester, Minnesota, USA.

Richard Jung (R)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada.

Zeeshan Ahmed (Z)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Louis Verreault-Julien (L)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Peter Kuhar (P)

Azumio Inc, Redwood City, San Francisco, USA.

Vincent Chan (V)

Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Talal Al-Atassi (T)

Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Hadi Toeg (H)

Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Jordan Bernick (J)

Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

George A Wells (GA)

School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Marc Ruel (M)

Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Benjamin Hibbert (B)

CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada bhibbert@ottawaheart.ca.
Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada.

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