We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions End Stage Renal Disease
Coronary Artery Disease
Intervention Other: Selective Screening
Enrollment 144
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description

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.

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.

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.
Period Title: Overall Study
Started 71 73
Completed 65 67
Not Completed 6 6
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             2             1
Physician Decision             1             1
Death             2             3
Arm/Group Title Selective Screening Regular Screening Total
Hide Arm/Group Description

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.

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 71 73 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 71 participants 73 participants 144 participants
51.80
(45.31 to 63.38)
54.98
(46.33 to 60.68)
52.26
(42.79 to 61.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 participants
Female
23
  32.4%
33
  45.2%
56
  38.9%
Male
48
  67.6%
40
  54.8%
88
  61.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 participants
Aboriginal
1
   1.4%
1
   1.4%
2
   1.4%
Asian
14
  19.7%
8
  11.0%
22
  15.3%
Black
8
  11.3%
2
   2.7%
10
   6.9%
Caucasian/White
29
  40.8%
18
  24.7%
47
  32.6%
Indian Sub-continent
6
   8.5%
1
   1.4%
7
   4.9%
Mid East/Arabian
4
   5.6%
3
   4.1%
7
   4.9%
Pacific Islander
4
   5.6%
3
   4.1%
7
   4.9%
Unknown
2
   2.8%
2
   2.7%
4
   2.8%
Other/Multiracial
3
   4.2%
3
   4.1%
6
   4.2%
Cause of End-Stage Renal Disease (ESRD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 participants
Diabetes Mellutis
15
  21.1%
18
  24.7%
33
  22.9%
Polycystic Kidney Disease
8
  11.3%
9
  12.3%
17
  11.8%
Glomerulonephritis
23
  32.4%
20
  27.4%
43
  29.9%
Hypertension
2
   2.8%
4
   5.5%
6
   4.2%
Other/Unknown
23
  32.4%
22
  30.1%
45
  31.3%
1.Primary Outcome
Title Number of Participants Adhering to the Expected Number of Screening Tests
Hide Description 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.
Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 71 73
Measure Type: Number
Unit of Measure: participants
59 71
2.Primary Outcome
Title Enrolment Rates
Hide Description 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.
Time Frame Measured after enrolment period of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 71 73
Measure Type: Count of Participants
Unit of Measure: Participants
St. Paul's Hospital
15
  21.1%
16
  21.9%
Vancouver General Hospital
12
  16.9%
12
  16.4%
Ottawa Hospital Research Institute
21
  29.6%
21
  28.8%
McGill
7
   9.9%
9
  12.3%
University Health Network
10
  14.1%
8
  11.0%
St. Joseph's Health Centre
6
   8.5%
7
   9.6%
3.Primary Outcome
Title Consent Rate
Hide Description 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.
Time Frame Measured after enrolment period of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants approached to consent to study.
Arm/Group Title Selective or Regular Screening
Hide Arm/Group Description:

Patients to be 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.

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.

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.

Overall Number of Participants Analyzed 211
Measure Type: Count of Participants
Unit of Measure: Participants
Consented
144
  68.2%
Declined
67
  31.8%
4.Secondary Outcome
Title Number of Participants With Cardiac Events
Hide Description A composite outcome of cardiac death and non-fatal myocardial infarction will be looked at and adjudicated by a blinded clinical endpoints committee.
Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 71 73
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiac Death
0
   0.0%
0
   0.0%
Non-Fatal Myocardial Infarction
4
   5.6%
3
   4.1%
5.Other Pre-specified Outcome
Title Number of Participants With Transplant Events
Hide Description Patient transplantation will be documented on the subject case report form.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 71 73
Measure Type: Count of Participants
Unit of Measure: Participants
36
  50.7%
39
  53.4%
6.Other Pre-specified Outcome
Title Number of Participants With Wait List Holds or Removals
Hide Description Indication for hold or removal will be measured as well.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
Wait List Holds
22
  84.6%
20
  83.3%
Wait List Removals
4
  15.4%
4
  16.7%
7.Other Pre-specified Outcome
Title Number of Health Care Encounters
Hide Description 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).
Time Frame Up to 27 months
Outcome Measure Data Not Reported
Time Frame Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted.
Adverse Event Reporting Description During each follow up visit, participants were reviewed/asked if any of the following adverse events happened: death, myocardial infarction, non-fatal cardiac arrest, stroke, bleeding, coronary angiogram, revascularization, and hospitalization ≥ 24 hours.
 
Arm/Group Title Selective Screening Regular Screening
Hide Arm/Group Description

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.

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.

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.
All-Cause Mortality
Selective Screening Regular Screening
Affected / at Risk (%) Affected / at Risk (%)
Total   2/71 (2.82%)   3/73 (4.11%) 
Hide Serious Adverse Events
Selective Screening Regular Screening
Affected / at Risk (%) Affected / at Risk (%)
Total   20/71 (28.17%)   18/73 (24.66%) 
Blood and lymphatic system disorders     
Bleeding   3/71 (4.23%)  6/73 (8.22%) 
Cardiac disorders     
Coronary Angiogram   5/71 (7.04%)  3/73 (4.11%) 
Non-Fatal Cardiac Arrest   3/71 (4.23%)  1/73 (1.37%) 
Myocardial Infarction   4/71 (5.63%)  3/73 (4.11%) 
Investigations     
Death   2/71 (2.82%)  3/73 (4.11%) 
Nervous system disorders     
Stroke   0/71 (0.00%)  1/73 (1.37%) 
Vascular disorders     
Revascularization   3/71 (4.23%)  1/73 (1.37%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Selective Screening Regular Screening
Affected / at Risk (%) Affected / at Risk (%)
Total   22/71 (30.99%)   17/73 (23.29%) 
Investigations     
Non-Transplant Hospitalization   22/71 (30.99%)  17/73 (23.29%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Gill
Organization: Kidney Transplant Research
Phone: 6046822344 ext 64706
EMail: jgill@providencehealth.bc.ca
Layout table for additonal information
Responsible Party: John Gill, University of British Columbia
ClinicalTrials.gov Identifier: NCT02082483    
Other Study ID Numbers: H14-00141
MOP 133509 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Submitted: March 6, 2014
First Posted: March 10, 2014
Results First Submitted: November 27, 2019
Results First Posted: February 11, 2020
Last Update Posted: February 11, 2020