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OpenTrials
Completed

NCT Number: NCT04656314

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Region Midt, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional MRI scan

Diagnostic Test

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

Primary outcomes

  1. Reproducibility

    Time frame: Results from scans performed with an interval of 1 to 2 weeks are compared

    Reproducibility as a coefficient of variation

  2. Physiological stress

    Time frame: Results from scans performed with an interval of 1 to 2 weeks are compared

    Quantified by level of cortisol and copeptin in blood samples.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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