Diagnostic Performance of Coronary CT Angiography With CT FFR in Kidney Transplantation Candidates (NCT03248674) | Clinical Trial Compass
TerminatedNot Applicable
Diagnostic Performance of Coronary CT Angiography With CT FFR in Kidney Transplantation Candidates
Stopped: Difficulty with recruitment in this patient population.
United States26 participantsStarted 2017-08-28
Plain-language summary
Patients with chronic kidney disease (CKD) before kidney transplantation require that obstructive coronary artery disease (CAD) is excluded, as cardiovascular complications are the leading cause of mortality in kidney transplant patients. However, in this patient population, the optimal method for the detection of obstructive CAD has not been identified. Noninvasive stress tests such as Dobutamine stress echocardiography or nuclear perfusion study have low diagnostic accuracy. CT fractional flow reserve measurement (CT FFR) is a novel non-invasive (FDA approved) imaging test to identify obstructive CAD. The goal of this project is to evaluate the diagnostic accuracy of CT FFR in the detection of obstructive coronary artery disease in patients with chronic kidney disease before kidney transplantation.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Candidates for kidney transplantation on dialysis without any residual kidney function AND referred to invasive coronary angiography for cardiac evaluation
* Referral to invasive coronary angiography is based on algorithm used at the Transplant Readiness Assessment Clinic (TRAC) at Stanford:
* A. Diabetic Candidates older than 45 years.
* B. Diabetic Candidates under 45 years old and any one of the following criteria is present:
* a) 25 year History of Diabetes
* b) 5 year Smoking History
* c) Abnormal EKG (ST-T wave changes)
Exclusion Criteria:
* Hemodynamically and clinically unstable condition (angina at rest, malignant arrhythmias)
* Known ischemic heart disease (prior, documented myocardial infarction, prior stenting or coronary artery bypass graft surgery)
* BMI\>30 kg/m2, or weight \>120 kg.
* Atrial fibrillation or other arrhythmia, \>6 ectopic beats per minute
* Known or suspected allergy to iodinated contrast medium
* Pregnancy cannot be excluded
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of CT FFR.
Timeframe: CT FFR and Invasive FFR are calculated immediately after coronary CT angiography and invasive coronary angiography