Coronary Artery Disease Screening in Kidney Transplant Candidates
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease; Coronary Artery Disease
Intervention: Selective Screening (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): John Gill, MD, Principal Investigator, Affiliation: St. Paul's Hospital
Overall contact: John Gill, MD, Phone: 604-682-2344, Ext: 69048, Email: jgill@providencehealth.bc.ca
Summary
Kidney transplant candidates are at very high risk for coronary artery disease (CAD). The
optimal strategy to monitor and maintain the cardiac fitness of patients awaiting kidney
transplantation is unknown. Currently patients undergo annual testing; however, screening
for CAD may increase morbidity and mortality by:
1. exposing patients to the risk of angiography and revascularization procedures
2. delaying or excluding patients from life saving transplantation.
Before proceeding with a definitive study to determine whether screening is necessary,
feasibility will be determined in this pilot study.
Clinical Details
Official title: Pilot Study to Determine Feasibility of a Randomized Trial of Screening for Coronary Artery Disease in Kidney Transplant Candidates
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Protocol AdherenceEnrolment Rates Consent Rate
Secondary outcome: Number of Participants with Cardiac Events
Detailed description:
This pilot trial will determine the feasibility of a multi-center, randomized, parallel
group definitive trial. Asymptomatic wait-listed patients will be randomized to routine
screening for coronary artery diesease (CAD) (i. e. Myocardial Perfusion Scintigraphy (MPS)
or Dobutamine Stress Echo (DSE)) as per the current standard of care versus selective
screening based on symptoms. Patients enrolled in the pilot will be included in the
definitive trial analysis. The pilot trial will include four Canadian centres. The
definitive trial will aim to determine if a strategy of selective use of screening tests
(i. e. Myocardial Perfusion Scintigraphy or Dobutamine Stress Echo) only in the presence of
symptoms (i. e. chest pain, dyspnea etc) is non-inferior with respect to the composite
endpoint of non-fatal MI and cardiac death compared to screening all asymptomatic
wait-listed patients at regular intervals as described in transplant specific guidelines
published by the National Kidney Foundation.
Currently there is no strong evidence for or against using routine cardiac screening of
asymptomatic transplant patients, more evidence based randomized clinical trials are needed.
This need is further highlighted by a number of factors such as: wait-listed patients are
increasing in number and medical complexity; longer wait times and changing donor
characteristics can increase CAD risk; wait-listed patients are at high risk for CAD but are
commonly asymptomatic; the standard of care is not evidence based and is expensive; the
current standard may be harmful. The study will determine feasibility of a definitive trial
through the measures outlined under 'Outcome Measures'.
End stage renal disease (ESRD) patients wait-listed for kidney transplantation will be
randomized to undergo selective screening for CAD, in which patients are only screened if
they develop symptoms suggestive of CAD or the current standard of care that involves
regular screening for CAD at fixed time intervals based on the presence of risk factors.
Patients will remain on the pilot trial protocol until death, non-fatal MI, transplantation,
permanent removal from the waiting list for any reason, or 24 months after enrolment in the
pilot trial. During wait-listing, follow-up telephone interviews and chart reviews will be
performed every six months. After transplantation, an in-person follow up visit and chart
review will occur at the time of discharge from hospital, and a telephone interview and
chart review will be performed 3 months after transplantation. Patients will be followed for
24 months from the date of enrolment. Patients who receive a kidney transplant during the
study will be followed for 27 months.
For the pilot trial, descriptive analyses are planned. Feasibility will be summarized with
proportions, rates, means, and medians as appropriate. Comparison of the definitive trial
outcomes between treatment groups, will not be done at the end of the internal pilot as
these patients will be included in the definitive trial. Analyses of enrolment rates and
consent rates will be done after the enrolment phase of the pilot trial in late 2014. An
interim analysis of protocol adherence is planned in mid 2016 in support of the definitive
trial funding application in September, 2016.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age greater than 18 years
- active on the deceased donor transplant waiting list
Exclusion Criteria:
- patients not expected to require further screening for CAD prior to transplantation
by the current standard of care. For example, a diabetic patient recently screened
for CAD and expected to be transplanted <12 months from the start of the study would
not require further screening according to current guidelines and would be ineligible
- patients with signs or symptoms suggestive of active cardiac disease such as unstable
coronary syndromes, de-compensated heart failure, uncontrolled arrhythmia, and severe
valvular heart disease
- patient who have been put "on hold" for transplantation due to a medical problem
(e. g. an infection)
- prior extra-renal transplant recipients
- multi-organ transplant candidates (e. g. kidney pancreas transplant candidates)
- patients with a planned living donor transplant
- patients unable to provide informed consent
Locations and Contacts
John Gill, MD, Phone: 604-682-2344, Ext: 69048, Email: jgill@providencehealth.bc.ca
St. Paul's Hospital, Vancouver, British Columbia, Canada; Recruiting
Vancouver General Hospital, Vancouver, British Columbia, Canada; Recruiting
The Ottawa Hospital, Ottawa, Ontario, Canada; Recruiting
University Health Network, Toronto, Ontario, Canada; Recruiting
Royal Victoria Hospital, Montreal, Quebec, Canada; Recruiting
Additional Information
Starting date: November 2014
Last updated: March 31, 2015
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