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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656314
• Other study ID #: 76158
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: March 27, 2021

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 27, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• Functional MRI scan
Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Midt

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility	Reproducibility as a coefficient of variation	Results from scans performed with an interval of 1 to 2 weeks are compared
Primary	Physiological stress	Quantified by level of cortisol and copeptin in blood samples.	Results from scans performed with an interval of 1 to 2 weeks are compared