Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

NCT03674307 | Recruiting DMC

• 1 other identifier: H16-01335_CARSK
• Study Type: interventional
• Target: 3,306
• Locations: 4 countries
• Sites: 22

Brief Summary

The Canadian Australasian Randomized Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease (CARSK) will test the hypothesis that eliminating the regular use of non-invasive screening tests for CAD AFTER waitlist activation is not inferior to regular (i.e., annual) screening for CAD during wait-listing for the prevention of Major Adverse Cardiac Events. Secondary analyses will assess the impact of screening on the rate of transplantation, and the relative cost-effectiveness of screening.

Conditions

Cardiovascular Diseases; End Stage Renal Disease; Kidney Transplantation; Dialysis Related Complication

Outcome Measures

Primary Outcomes (1)

• MACE

  Primary efficacy: major adverse cardiac event (MACE), defined as any of the following: cardiovascular death, myocardial infarction, emergency revascularisation, hospitalisation with unstable angina. The outcome will be assessed by: 1. Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in waitlisted patients). 2. The trial coordinator will gather electronic medical records, letters, procedure notes, and will fill in the relevant case record form on the REDCap database (managed by Sydney local health district). All data are encrypted and stored on servers at SLHD, where it is backed up. 3. Patients will be followed up 6-monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisation with the patients.

  The investigators will analyse time to first MACE event for the duration of the trial (60 months), depending on patient's date of transplant. Follow-up will be 12 months posttransplant. Maximum follow-up is 72 months.

Secondary Outcomes (10)

• All-cause death

  Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

• Emergency revascularisation

  Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

• Stroke

  Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

• Health related quality of life

  Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

• Time of wait-listing

  Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

Study Arms (2)

No screening

EXPERIMENTAL

No further screening for asymptomatic coronary artery disease after wait-list entry

Other: No screening

Regular screening

ACTIVE COMPARATOR

Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry

Other: Regular Screening

Interventions

No screening OTHER

No further screening for asymptomatic coronary artery disease after wait-list entry

No screening

Regular Screening OTHER

Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry

Regular screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18 years of age or older
• Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
• expected to require further screening for CAD prior to transplantation (by current standard of care);
• able to give consent;
• anticipated to undergo transplantation more than 12 months from date of enrolment

You may not qualify if:

• patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease;
• patients who "on-hold" for transplantation due to a medical problem;
• patients with other solid organ transplants;
• multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates);
• patients with planned living donor transplant;
• patients unable to give consent.

Sponsors & Collaborators

• University of British Columbia: lead
• University of Sydney: collaborator

Study Sites (22)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

The George Washington University

Washington D.C., District of Columbia, 20052, United States

RECRUITING

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Dalhousie University

Halifax, Nova Scotia, B3H 1V8, Canada

RECRUITING

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Kingston Health Science Centre

Kingston, Ontario, Canada

RECRUITING

London Health Science Centre

London, Ontario, Canada

RECRUITING

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

St Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec

Laval, Quebec, Canada

RECRUITING

University of Montreal, Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Universite de Montreal, Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

RECRUITING

St. Paul's Hospital, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

RECRUITING

Charité Universitätsmedizin

Berlin, Germany

NOT YET RECRUITING

Sussex Brighton R&D

Brighton, BN2 1ES, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

Brixton, SW9 8RR, United Kingdom

RECRUITING

Epsom and St Helier University Hospitals NHS Trust

Carshalton, SM5 1AA, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 4UJ, United Kingdom

RECRUITING

St George's University Hospital NHS Trust Foundation

London, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• Ying T, Gill J, Webster A, Kim SJ, Morton R, Klarenbach SW, Kelly P, Ramsay T, Knoll GA, Pilmore H, Hughes G, Herzog CA, Chadban S, Gill JS. Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease-A trial protocol for the CARSK study. Am Heart J. 2019 Aug;214:175-183. doi: 10.1016/j.ahj.2019.05.008. Epub 2019 May 22.

  PMID: 31228771 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jagbir Gill, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breanna Riou-Green

CONTACT

1-604-682-2344; aogniben@providencehealth.bc.ca

Gurvir Thind

CONTACT

1-604-682-2344; Briougreen@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 17, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (2); GB (5); DE (1); CA (14)