Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: Functional MRI scan

• Registration Number: NCT04656314
• Lead Sponsor: University of Aarhus

Brief Summary

The main purpose of the study is to describe the applicability and reproducibility of functional MRI scans of the kidneys in healthy participants. Furthermore, the study examines to what extent physiological stress caused by lying in a scanner affects the renal perfusion and thus the reproducibility

Detailed Description

2 groups of 10 healthy participants each are included. 1 group aged 18 to 40 and a group of participants above 60 years of age.

The functional MRI sequences are performed consecutively in a protocol set up on a 1,5 T MRI scanner.

In totl, 3 identical scans are being performed. 2 scans on day 1 followed by another scan 1-2 weeks later. Before and after each scan, cortisol and copeptin is controlled in a blood sample to quantify the level of physiological stress.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2021-01-15
• Primary Completion: 2021-03-27
• Study Completion: 2021-03-27
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age between 18 and 40
• Age of 60 or above

Exclusion Criteria

• Known kidney or cardiovascular disease
• Medicine of any kind, that must be taken on days of scanning
• MRi incompatible implants or other contraindications to MRi
• Claustrophobia
• Not being able to lie still in an hour
• Body weight above 110 kg or waist circumference above 95 cm
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy participants aged 60 and above	Functional MRI scan	3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan.
Healthy participants aged 18 to 40	Functional MRI scan	3 identical functional MRI scans. Blood samples to quantify level of physiological stress are taken before and after each scan.

Primary Outcome Measures

Name	Time	Method
Reproducibility	Results from scans performed with an interval of 1 to 2 weeks are compared	Reproducibility as a coefficient of variation
Physiological stress	Results from scans performed with an interval of 1 to 2 weeks are compared	Quantified by level of cortisol and copeptin in blood samples.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Region Midt, Denmark