End Stage Renal DiseaseCADScreeningNCT02082483
Coronary Artery Disease Screening in Kidney Transplant Candidates
A study testing Selective Screening in people with End Stage Renal Disease and Coronary Artery Disease, run by University of British Columbia at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Coronary Artery Disease
- What is being tested?
- Selective Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesCanada
- Study dates
- Nov 2014to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than 18 years
- active on the deceased donor transplant waiting list
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Royal Victoria Hospital
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
University Health Network
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Pilot Study to Determine Feasibility of a Randomized Trial of Screening for Coronary Artery Disease in Kidney Transplant Candidates
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:
- exposing patients to the risk of angiography and revascularization procedures
- 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.
Read the 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 disease (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.
- Conditions
- End Stage Renal Disease, Coronary Artery Disease
- Being tested
- Selective Screening
- Keywords
- Kidney Transplant, Screening
- Medical subject headings
- Kidney Failure, Chronic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective ScreeningOther
Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Selective Screening | Experimental | Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care. Receives: Other: Selective Screening |
| Regular Screening | No intervention | Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Adhering to the Expected Number of Screening Tests
Adherence will be defined by completion of the expected number of screening tests during follow up as per the 2005 National Kidney Foundation guidelines. For example, the expected number of screening tests in a diabetic patient who did not develop symptoms would be zero in the selective screening group, while the same patient would be expected to completed two screening tests if randomized to regular screening. Tests performed for clinical symptoms of CAD will be excluded from the determination of adherence.
Measured: Up to 27 months
Enrolment Rates
The total number of subjects enrolled across all sites will be monitored monthly from the CRO, Ottawa Hospital Research Institute (OHRI), which issues the randomization scheme.
Measured: Measured after enrolment period of 6 months
Consent Rate
The percentage of patients willing to participate will be established at each site. Willingness to enrol in the study will be recorded on each patient's case report form along with the reason for any refusal to consent.
Measured: Measured after enrolment period of 6 months
Secondary outcomes (1)
Number of Participants With Cardiac Events
A composite outcome of cardiac death and non-fatal myocardial infarction will be looked at and adjudicated by a blinded clinical endpoints committee.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, John Gill, University of British Columbia
- Investigators
- John Gill, MD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082483
- Sponsor's protocol ID
- H14-00141
- Other IDs
- MOP 133509
- Acronym
- CADScreening
- Status last verified
- May 2024
- First submitted
- 6 Mar 2014
- Last updated
- 13 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine Feasibility of a Randomized Trial of Screening for Coronary Artery Disease in Kidney Transplant Candidates
- ClinicalTrials.gov ID
- NCT02082483
- Acronym / sponsor ID
- CADScreening / H14-00141
- Conditions
- End Stage Renal Disease, Coronary Artery Disease
- Keywords
- Kidney Transplant, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2014 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- exposing patients to the risk of angiography and revascularization procedures
- 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.
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 disease (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective Screening | Experimental | Other: Selective ScreeningPatients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care. |
| Regular Screening | No intervention | –Patients randomized to regular screening will be tested as per the current standard described in guidelines published by the National Kidney Foundation (e.g. annually while wait-listed for transplantation). If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age greater than 18 years
- active on the deceased donor transplant waiting list
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective ScreeningPatients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care. | Other | Selective Screening |
Primary outcome
Number of Participants Adhering to the Expected Number of Screening Tests
Time frame: Up to 27 months
Adherence will be defined by completion of the expected number of screening tests during follow up as per the 2005 National Kidney Foundation guidelines. For example, the expected number of screening tests in a diabetic patient who did not develop symptoms would be zero in the selective screening group, while the same patient would be expected to completed two screening tests if randomized to regular screening. Tests performed for clinical symptoms of CAD will be excluded from the determination of adherence.
Enrolment Rates
Time frame: Measured after enrolment period of 6 months
The total number of subjects enrolled across all sites will be monitored monthly from the CRO, Ottawa Hospital Research Institute (OHRI), which issues the randomization scheme.
Consent Rate
Time frame: Measured after enrolment period of 6 months
The percentage of patients willing to participate will be established at each site. Willingness to enrol in the study will be recorded on each patient's case report form along with the reason for any refusal to consent.
1 secondary outcome
Number of Participants With Cardiac Events
Time frame: Up to 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gill, MD principal investigator
St. Paul's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Screening in people with End Stage Renal Disease and Coronary Artery Disease, run by University of British Columbia at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Adhering to the Expected Number of Screening Tests (time frame: Up to 27 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.