Trial Outcomes & Findings for Coronary Artery Disease Screening in Kidney Transplant Candidates (NCT NCT02082483)

NCT ID: NCT02082483

Last Updated: 2024-05-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

Up to 27 months

Results posted on

2024-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	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.
Overall Study STARTED	71	73
Overall Study COMPLETED	65	67
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	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.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	1	1
Overall Study Death	2	3

Baseline Characteristics

Coronary Artery Disease Screening in Kidney Transplant Candidates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selective Screening n=71 Participants 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.	Regular Screening n=73 Participants 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 n=144 Participants Total of all reporting groups
Age, Continuous	51.80 years n=5 Participants	54.98 years n=7 Participants	52.26 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Black	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/White	29 Participants n=5 Participants	18 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Indian Sub-continent	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Mid East/Arabian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other/Multiracial	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Cause of End-Stage Renal Disease (ESRD) Diabetes Mellutis	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Cause of End-Stage Renal Disease (ESRD) Polycystic Kidney Disease	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Cause of End-Stage Renal Disease (ESRD) Glomerulonephritis	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Cause of End-Stage Renal Disease (ESRD) Hypertension	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Cause of End-Stage Renal Disease (ESRD) Other/Unknown	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 27 months

Outcome measures

Outcome measures
Measure	Selective Screening n=71 Participants 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.	Regular Screening n=73 Participants 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.
Number of Participants Adhering to the Expected Number of Screening Tests	59 participants	71 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Selective Screening n=71 Participants 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.	Regular Screening n=73 Participants 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.
Enrolment Rates St. Paul's Hospital	15 Participants	16 Participants
Enrolment Rates Vancouver General Hospital	12 Participants	12 Participants
Enrolment Rates Ottawa Hospital Research Institute	21 Participants	21 Participants
Enrolment Rates McGill	7 Participants	9 Participants
Enrolment Rates University Health Network	10 Participants	8 Participants
Enrolment Rates St. Joseph's Health Centre	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Measured after enrolment period of 6 months

Population: Number of participants approached to consent to study.

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.

Outcome measures

Outcome measures
Measure	Selective Screening n=211 Participants 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.	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.
Consent Rate Consented	144 Participants	—
Consent Rate Declined	67 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Selective Screening n=71 Participants 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.	Regular Screening n=73 Participants 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.
Number of Participants With Cardiac Events Cardiac Death	0 Participants	0 Participants
Number of Participants With Cardiac Events Non-Fatal Myocardial Infarction	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 24 months

Patient transplantation will be documented on the subject case report form.

Outcome measures

Outcome measures
Measure	Selective Screening n=71 Participants 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.	Regular Screening n=73 Participants 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.
Number of Participants With Transplant Events	36 Participants	39 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 24 months

Indication for hold or removal will be measured as well.

Outcome measures

Outcome measures
Measure	Selective Screening n=26 Participants 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.	Regular Screening n=24 Participants 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.
Number of Participants With Wait List Holds or Removals Wait List Holds	22 Participants	20 Participants
Number of Participants With Wait List Holds or Removals Wait List Removals	4 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

Selective Screening

Serious events: 20 serious events

Other events: 22 other events

Deaths: 2 deaths

Regular Screening

Serious events: 18 serious events

Other events: 17 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Selective Screening n=71 participants at risk 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.	Regular Screening n=73 participants at risk 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.
Blood and lymphatic system disorders Bleeding	4.2% 3/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	8.2% 6/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.
Cardiac disorders Coronary Angiogram	7.0% 5/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	4.1% 3/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.
Investigations Death	2.8% 2/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	4.1% 3/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.
Cardiac disorders Non-Fatal Cardiac Arrest	4.2% 3/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	1.4% 1/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.
Cardiac disorders Myocardial Infarction	5.6% 4/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	4.1% 3/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.
Vascular disorders Revascularization	4.2% 3/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	1.4% 1/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.
Nervous system disorders Stroke	0.00% 0/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	1.4% 1/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.

Other adverse events

Other adverse events
Measure	Selective Screening n=71 participants at risk 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.	Regular Screening n=73 participants at risk 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.
Investigations Non-Transplant Hospitalization	31.0% 22/71 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.	23.3% 17/73 • Adverse event data was collected 24 months from the date of enrollment and 3 months after transplantation date for those patients transplanted. 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.

Additional Information

Dr. John Gill

Kidney Transplant Research

Phone: 6046822344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place