Coronary Artery Disease Screening in Kidney Transplant Candidates

NCT02082483 | Completed Results DMC

• 2 other identifiers: H14-00141MOP 133509
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 6

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. 1.exposing patients to the risk of angiography and revascularization procedures
2. 2.delaying or excluding patients from life saving transplantation.

Conditions

End Stage Renal Disease; Coronary Artery Disease

Keywords

Kidney Transplant; Screening

Outcome Measures

Primary Outcomes (3)

• 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.

  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 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 after enrolment period of 6 months

Secondary Outcomes (1)

• Number of Participants With Cardiac Events

  Up to 27 months

Other Outcomes (3)

• Number of Participants With Transplant Events

  Up to 24 months

• Number of Participants With Wait List Holds or Removals

  Up to 24 months

• Number of Health Care Encounters

  Up to 27 months

Study Arms (2)

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.

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.

Interventions

Selective Screening OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years
• active on the deceased donor transplant waiting list

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. John Gill
• Organization: Kidney Transplant Research

jgill@providencehealth.bc.ca

6046822344

Study Officials

• John Gill, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. John Gill

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: July 31, 2019
• Last Updated: May 13, 2024
• Results First Posted: February 11, 2020

Record last verified: 2024-05

Locations

CA (6)