Canadian-Australian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease

Not Applicable

Recruiting

• Conditions: Kidney failure; Kidney transplant; Coronary artery disease; Renal and Urogenital - Kidney disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12616000736448
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-03
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3306

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy: major adverse cardiac event (MACE), defined as any of the following: cardiovascular death, myocardial infarction, emergency revascularisation, hospitalisation with unstable angina.<br><br>The outcome will be assessed by:<br>1) Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in wait-listed patients).<br>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.<br>3) Patients will be followed up 6 monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisations with the patients.[We will analyse time to first MACE event for the duration of the trial (5-years)]