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 range21 Years

SexALL

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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

What they're measuring

Diagnostic accuracy of CT FFR.

Timeframe: CT FFR and Invasive FFR are calculated immediately after coronary CT angiography and invasive coronary angiography

Trial details

NCT IDNCT03248674

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-24