Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography

NCT06332456 | Completed

• 1 other identifier: ICM 2023-3169
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Microcirculation With Rubidium Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

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

  Average difference of RBF between healthy controls and CKD participants

  1 day

Secondary Outcomes (3)

• 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 Arms (2)

Control

15 healthy volunteers

CKD

15 patients with CKD and CAD risk factors with GFR between 30 and 45 mL/min/1.73m2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. 15 healthy volunteers 2. 15 patients with CKD and CAD risk factors with GFR between 30 and 45 mL/min/1.73m2 from HFpEF clinic at ICM

You may qualify if:

• Control Group
• Age ≥ 18 years and \< 80 years
• Signed informed consent
• No medical history of renal disease
• CKD Group
• 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

You may not qualify if:

• Control Group
• Hypertension
• Diabetes
• Dyslipidemia
• Active smoking within the last 12 month
• Left ventricular ejection fraction \<45%
• BMI \>45 kg/m2
• Severe aortic stenosis
• CKD Group
• Left ventricular ejection fraction \<45%
• BMI \>45 kg/m2
• Severe aortic stenosis
• Changes in medical therapy within the last 4 weeks
• Documented renal artery stenosis
• Known structural cause of CKD including polycystic kidney disease, obstruction, or other post-renal causes

Sponsors & Collaborators

• Matthieu Pelletier-Galarneau, MD MSc: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 27, 2024
• Study Start: July 4, 2023
• Primary Completion: November 21, 2024
• Study Completion: November 22, 2024
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

CA (1)