Ignite Creation Date:
2024-05-06 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03674307
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2018-09-05
Brief Title:
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARSK
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 ie 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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None