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Clinical Trials/NCT06332456
NCT06332456
Completed
Not Applicable

Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography: A Proof-of-Concept Study

Matthieu Pelletier-Galarneau, MD MSc1 site in 1 country30 target enrollmentJuly 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Microcirculation With Rubidium Positron Emission Tomography
Sponsor
Matthieu Pelletier-Galarneau, MD MSc
Enrollment
30
Locations
1
Primary Endpoint
Renal blood flow in units of mL/min/100g
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases.

Detailed Description

2. Hypothesis 1. We hypothesize that RBF assessed with rubidium PET is on average lower in patients with CKD. To test our hypothesis, RBF of patients with CKD and coronary artery disease (CAD) risk factors, a population characterized by renal microvascular rarefaction, will be compared to RBF of healthy controls. 2. We hypothesize that RVR assessed with rubidium PET correlates with echographic measurements of renal resistance index (RI), the current non-invasive method of choice. 3. We hypothesize that RBF quantification with rubidium PET is technically reproducible, meaning that the variation on the measurements of RBF purely attributable to technical factors (camera, positioning, tracer injection, etc.) is relatively small. To test this hypothesis, two PET scans will be acquired within a short time period. 3. Objectives and Endpoints 3.1. Primary Objective 1) To compare RBF of patients with CKD and CAD risk factors to healthy controls 3.2. Secondary Objectives 1. To compare RVR of patients with CKD and CAD risk factors to healthy controls 2. To evaluate the correlation between RVR measured with PET to renal RI as measured with echography 3. To evaluate the repeatability and reproducibility of in vivo measurements of RBF and RVR

Registry
clinicaltrials.gov
Start Date
July 4, 2023
End Date
November 22, 2024
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Matthieu Pelletier-Galarneau, MD MSc
Responsible Party
Sponsor Investigator
Principal Investigator

Matthieu Pelletier-Galarneau, MD MSc

MD MSc

Montreal Heart Institute

Eligibility Criteria

Inclusion Criteria

  • Control Group
  • Age ≥ 18 years and \< 80 years
  • Signed informed consent
  • No medical history of renal disease
  • Age ≥ 18 years and \< 80 years
  • Signed informed consent
  • GFR between 30 and 45 mL/min/1.73m2 measured within the last 3 months
  • At least two cardiovascular disease risk factors such as hypertension, smoking, diabetes, obesity, and dyslipidemia

Exclusion Criteria

  • Control Group
  • Hypertension
  • Dyslipidemia
  • Active smoking within the last 12 month
  • Left ventricular ejection fraction \<45%
  • BMI \>45 kg/m2
  • Severe aortic stenosis
  • Left ventricular ejection fraction \<45%
  • BMI \>45 kg/m2
  • Severe aortic stenosis

Outcomes

Primary Outcomes

Renal blood flow in units of mL/min/100g

Time Frame: 1 day

Average difference of RBF between healthy controls and CKD participants

Secondary Outcomes

  • Renal vascular resistance in units of mmHg/mL/min/100g(1 day)
  • Correlation between renal vascular resistance measured with PET and measured with echography(Up to 4 weeks)
  • Coefficient of repeatability of renal blood flow(1 day)

Study Sites (1)

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