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

December 16, 2021 updated by: Dominik Fleischmann, MD, Stanford University

Diagnostic Performance of Coronary Computed Tomography Angiography With Computed Tomography Fractional Flow Reserve in Kidney Transplantation Candidates

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Transplantation is the therapy of choice for most patients with stage 5 chronic kidney disease (CKD) and end stage renal disease (ESRD). Kidney transplantation improves quality of life and overall survival rates. Cardiovascular disease is the most common complication and leading cause of death in the transplant population. In order to assess the risk of cardiac events perioperatively and after kidney transplantation, the majority of kidney transplantation candidates undergo cardiac evaluation, including non-invasive cardiac stress imaging or invasive coronary angiography before transplantation. Invasive coronary angiography is associated with small but definite risk of bleeding or myocardial infarction, making non-invasive cardiac stress imaging such as dobutamine stress echocardiography (DSE) or nuclear myocardial perfusion scintigraphy (MPS) the preferred method. However, non-invasive cardiac stress imaging in patients with stage 5 CKD and ESRD demonstrates only moderate accuracy. DSE and MPS showed only sensitivities ranging from 0.44 to 0.89 and from 0.29 to 0.92, respectively, for identifying one or more severe coronary artery stenosis (defined as coronary diameter stenosis of more than 70%). Due to the moderate accuracy, several transplant centers (including Stanford) still continue to rely on invasive coronary angiography for their populations instead of non-invasive cardiac testing. Thus improved non-invasive cardiac testing with higher sensitivities and specificity are highly desirable in this patient population.

A promising alternative is the use of coronary CT angiography (cCTA) in combination with CT based fractional flow reserve (CT-FFR). Non-invasive cCTA alone has recently been evaluated in kidney transplantation candidates. It demonstrated high sensitivity (0.93) but limited specificity (0.63) in the detection of obstructive coronary artery disease, most likely related to the high prevalence of coronary artery calcifications in patients with CKD and ESRD. The specificity of coronary CTA can be improved by a new image analysis techniques, which allow the calculation of the hemodynamic significance - expressed as the relative pressure drop across a lesion similar - based on computational fluid dynamics derived from the conventional coronary CTA (6). In various study populations, the combination of coronary CT angiography and CT FFR showed excellent correlation with invasive FFR derived from invasive coronary angiography, which is the current gold standard. The implementation of CT- FFR has shown an improvement of the specificity of coronary CTA , even in the presence of coronary artery calcifications. However, no study so far assessed the diagnostic accuracy of coronary angiography with CT-FFR in candidates for kidney transplantation.

Goal The objective of this project is to evaluate and establish a new non-invasive cardiac test in the detection of coronary artery disease for candidates before kidney transplantation.

Specific Aims We want to confirm the promising results of CT FFR in this specific patient population and want to establish an alternative non-invasive cardiac test.

Study Design This study is designed as a prospective observational cohort study with a study population of 50 -100 patients. All patients who are included in this study will undergo coronary CT angiography with CT-FFR (research part) and a clinically indicated invasive coronary angiography with invasive FFR (standard of care). Coronary angiography and invasive FFR will act as the reference standard.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of CT FFR.
Time Frame: CT FFR and Invasive FFR are calculated immediately after coronary CT angiography and invasive coronary angiography
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Siemens Medical Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominik Fleischmann, M.D., Stanford Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-41455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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