Diagnostic Performance of Coronary CT Angiography With CT FFR in Kidney Transplantation Candidates

NCT03248674 | Terminated FDA Device

• 1 other identifier: IRB-41455
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CT FFR.

  Diagnostic accuracy of CT FFR (per vessel) in the detection of hemodynamically significant CAD as compared to invasive FFR derived from invasive coronary angiography (reference standard). Presence or absence of hemodynamically significant coronary artery disease in concordance between CT FFR and invasive FFR. Hemodynamically significant stenosis is defined as CT FFR value below 0.8.

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

Interventions

CT FFR DIAGNOSTIC_TEST

CT FFR calculated the fractional flow reserve based on the data derived for a regular coronary CT angiography. Computation is based on development of an anatomic model of the epicardial coronary arteries for each case and calculating the maximum coronary flow during maximal hyperaemia based on a mathematical model incorporating fluid dynamics. These post-processing steps require quantification of the patient-specific myocardial mass as this allows for an estimation of the baseline coronary blood flow.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Candidates for kidney transplantation without any residual kidney function and referred to cardiac evaulation.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Stanford Healthcare

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dominik Fleischmann, M.D.

  Stanford Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: August 28, 2017
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)