Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

NCT ID: NCT03674307

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Cardiovascular disease is the commonest cause of death while on the kidney transplant waiting list and after transplantation. Current standard care involves screening for coronary artery disease prior to waitlist entry, then every 1-2 years, according to perceived risk, until transplanted. The aim of screening is two-fold. Firstly to identify patients with asymptomatic coronary disease to enable either correction, by bypass surgery or angioplasty, or removal of the patient from the list, with the ultimate aim of preventing premature cardiovascular mortality at the time of, or soon after kidney transplantation. Secondly, from a societal perspective, to prevent mis-direction of scarce donor organs into recipients who experience early mortality. This current screening strategy is not evidence based, has substantial known and potential harms, and is very costly. Two major issues of uncertainty require addressing in sequence: (1) whether to periodically screen asymptomatic wait-listed patients for occult coronary artery disease; and (2) whether to revascularise coronary stenoses in asymptomatic patients prior to transplantation. The CARSK study seeks to address the first of these 2 issues.

CARSK aims to

1. Test the hypothesis that after screening for wait list entry, no further screening for coronary artery disease (CAD) is non-inferior to the current standard care which is screening all asymptomatic wait-listed patients for CAD at regular intervals.
2. Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.

Conditions

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Cardiovascular Diseases End Stage Renal Disease Kidney Transplantation Dialysis Related Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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No screening

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

Group Type EXPERIMENTAL

No screening

Intervention Type OTHER

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

Regular screening

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

Group Type ACTIVE_COMPARATOR

Regular Screening

Intervention Type OTHER

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

Interventions

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No screening

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

Intervention Type OTHER

Regular Screening

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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;
2. patients who "on-hold" for transplantation due to a medical problem;
3. patients with other solid organ transplants;
4. multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates);
5. patients with planned living donor transplant;
6. patients unable to give consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sydney

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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John Gill

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jagbir Gill, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status RECRUITING

The George Washington University

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

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Dalhousie University

Halifax, Nova Scotia, Canada

Site Status RECRUITING

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status RECRUITING

Kingston Health Science Centre

Kingston, Ontario, Canada

Site Status RECRUITING

London Health Science Centre

London, Ontario, Canada

Site Status RECRUITING

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

St Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

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

Laval, Quebec, Canada

Site Status RECRUITING

University of Montreal, Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Universite de Montreal, Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status RECRUITING

St. Paul's Hospital, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Charité Universitätsmedizin

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Sussex Brighton R&D

Brighton, , United Kingdom

Site Status RECRUITING

King's College Hospital NHS Foundation Trust

Brixton, , United Kingdom

Site Status RECRUITING

Epsom and St Helier University Hospitals NHS Trust

Carshalton, , United Kingdom

Site Status RECRUITING

Barts Health NHS Trust

London, , United Kingdom

Site Status RECRUITING

St George's University Hospital NHS Trust Foundation

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Canada Germany United Kingdom

Central Contacts

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Breanna Riou-Green

Role: CONTACT

1-604-682-2344 ext. 64708

Gurvir Thind

Role: CONTACT

1-604-682-2344 ext. 64706

Facility Contacts

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Nicole Marquez

Role: primary

Taimur Malik

Role: primary

Anureet Tiwana

Role: primary

Jessica Pinder

Role: backup

Breanna Riou-Green

Role: primary

1-604-682-2344 ext. 64708

Laura Sills

Role: primary

1-902-473-7625

Madison Salisbury

Role: primary

1-905-522-1155 ext. 34799

Muhammed Shahriar Zaman

Role: primary

Samantha Parsons

Role: primary

519-685-8500 ext. 34755

Erin Thomas

Role: primary

1-613-738-8400 ext. 81622

Michael Ricci-Bonzey

Role: backup

Michelle Minkovich

Role: primary

1-416-340-4800 ext. 2012

Michelle Nash

Role: primary

416-867-3692

France Samson

Role: primary

Lucie Boutin

Role: primary

1-514-252-3400 ext. 6500

Ayat Salman

Role: primary

514-934-1934 ext. 36889

Majda Belkaid

Role: primary

514 890-8000 ext. 28241

Adeola Adesokan

Role: primary

306-978-8306

Eva Vanessa Schrezenmeier

Role: primary

Zdenka Cipinova

Role: primary

Pearl Dulawan

Role: primary

Eva Garcia

Role: primary

Anika Anderson

Role: primary

Debasish Bannerjee, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31228771 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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H16-01335_CARSK

Identifier Type: -

Identifier Source: org_study_id

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