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Coronary Artery Disease Screening in Kidney Transplant Candidates (CADScreening)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082483
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
John Gill, University of British Columbia

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 10, 2014
Results First Submitted Date  ICMJE November 27, 2019
Results First Posted Date  ICMJE February 11, 2020
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
  • Protocol Adherence [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
Number of Participants With Cardiac Events [ Time Frame: Up to 27 months ]
A composite outcome of cardiac death and non-fatal myocardial infarction will be looked at and adjudicated by a blinded clinical endpoints committee.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Number of Participants with Cardiac Events [ Time Frame: Up to 27 months ]
A composite outcome of cardiac death and non-fatal myocardial infarction will be looked at and adjudicated by a blinded clinical endpoints committee.
Current Other Pre-specified Outcome Measures
 (submitted: February 4, 2020)
  • Number of Participants With Transplant Events [ Time Frame: Up to 24 months ]
    Patient transplantation will be documented on the subject case report form.
  • Number of Participants With Wait List Holds or Removals [ Time Frame: Up to 24 months ]
    Indication for hold or removal will be measured as well.
  • Number of Health Care Encounters [ Time Frame: Up to 27 months ]
    The information captured will include outpatient, day care, and emergency room use (including any diagnostic testing and all medical and surgical interventions (i.e. use of thrombolytics, revascularization procedures), inpatient encounters and resource utilization (hospitalizations, procedural costs), physician consultations. Indirect patients costs (time off work, transportation costs), and quality of life (measured using the short-form 36 (SF36).
Original Other Pre-specified Outcome Measures
 (submitted: March 6, 2014)
  • Number of Transplant Events [ Time Frame: Up to 24 months ]
    Patient transplantation will be documented on the subject case report form.
  • Number of Wait List Holds or Removals [ Time Frame: Up to 24 months ]
    Indication for hold or removal will be measured as well.
  • Number of Health Care Encounters [ Time Frame: Up to 27 months ]
    The information captured will include outpatient, day care, and emergency room use (including any diagnostic testing and all medical and surgical interventions (i.e. use of thrombolytics, revascularization procedures), inpatient encounters and resource utilization (hospitalizations, procedural costs), physician consultations. Indirect patients costs (time off work, transportation costs), and quality of life (measured using the short-form 36 (SF36).
 
Descriptive Information
Brief Title  ICMJE Coronary Artery Disease Screening in Kidney Transplant Candidates
Official Title  ICMJE Pilot Study to Determine Feasibility of a Randomized Trial of Screening for Coronary Artery Disease in Kidney Transplant Candidates
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease
  • Coronary Artery Disease
Intervention  ICMJE Other: Selective Screening
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 Arms  ICMJE
  • Experimental: Selective Screening
    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.
    Intervention: Other: Selective Screening
  • No Intervention: Regular Screening
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
144
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02082483
Other Study ID Numbers  ICMJE H14-00141
MOP 133509 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party John Gill, University of British Columbia
Original Responsible Party University of British Columbia
Current Study Sponsor  ICMJE University of British Columbia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: John Gill, MD St. Paul's Hospital
PRS Account University of British Columbia
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP