NCT02746549

Brief Summary

In this study we want to compare the accuracy of two methods to measure renal perfusion by MRI spin labelling technique: the first measurement done with the 1.5 T MRI versus the second one obtained with the 3.0 T MRI (Siemens MRI device). Additionally we want to compare the changes of renal perfusion caused by physiological stress. The used stress test is the cold pressor test done at the forehead.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4.8 years

First QC Date

October 8, 2015

Last Update Submit

March 25, 2020

Conditions

HypertensionChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Accuracy of 1.5 T versus 3 T magnetic resonance arterial spin labeling to measure renal perfusion (ml/min)

    Renal function will be measured in ml/min by MRI arterial spin labelling technique.

    2 weeks

Study Arms (2)

1.5 Tesla MRI

EXPERIMENTAL

Measurement of renal perfusion by 1.5 Tesla MRI with arterial spin labelling

Other: renal perfusion

3.0 Tesla MRI

EXPERIMENTAL

Measurement of renal perfusion by 3.0 Tesla MRI with arterial spin labelling

Other: renal perfusion

Interventions

renal perfusionOTHER

measurement of renal perfusion with MRI arterial spin labelling technique

1.5 Tesla MRI3.0 Tesla MRI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female patients are eligible. Females of child bearing potential (WOCBP) are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial.
  • Healthy volunteers and patients who have hypertension stage 1 or 2 or patients who have diabetes at a max of 2 oral antidiabetic agents will be included

You may not qualify if:

  • eGFR ≤ 45 ml/min/1.75m²
  • any cardiovascular or cerebrovascular other other severe events within the last 3 months
  • arterial hypertension grad \> 2 ( blood pressure ≥ 180/110)
  • Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
  • Any contraindications to MRI
  • Brain aneurysm clip
  • Implanted cardiac pacemaker, pacemaker wires or defibrillator
  • Prosthetic heart valves
  • Cochlear implant
  • Ocular foreign body
  • Implanted insulin pump,
  • Tattoo (as determined by imager)
  • agoraphobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg

Erlangen, 91054, Germany

Location

Related Publications (1)

  • Hammon M, Janka R, Siegl C, Seuss H, Grosso R, Martirosian P, Schmieder RE, Uder M, Kistner I. Reproducibility of Kidney Perfusion Measurements With Arterial Spin Labeling at 1.5 Tesla MRI Combined With Semiautomatic Segmentation for Differential Cortical and Medullary Assessment. Medicine (Baltimore). 2016 Mar;95(11):e3083. doi: 10.1097/MD.0000000000003083.

    PMID: 26986143BACKGROUND

MeSH Terms

Conditions

HypertensionRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roland E. Schmieder, MD

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

April 21, 2016

Study Start

May 1, 2014

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

DE(1)