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Accuracy of 1.5 T Versus 3 T Magnetic Resonance Arterial Spin Labeling to Measure Renal Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02746549
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE April 21, 2016
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Accuracy of 1.5 T versus 3 T magnetic resonance arterial spin labeling to measure renal perfusion (ml/min) [ Time Frame: 2 weeks ]
Renal function will be measured in ml/min by MRI arterial spin labelling technique.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accuracy of 1.5 T Versus 3 T Magnetic Resonance Arterial Spin Labeling to Measure Renal Blood Flow
Official Title  ICMJE Randomized, Clinical Study to Compare Accuracy of 1.5 T Versus 3 T Magnetic Resonance Arterial Spin Labeling to Measure Renal Blood Flow and the Changes of Renal Perfusion Caused by Physiological Stress (Cold Pressor Test).
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.

Detailed Description

Magnetic resonance imaging based arterial spin labeling is a technique to measure renal blood flow. Renal perfusion measurement is an important tool to analyze renal function and to detect acute kidney injury. The perfusion measurement is based on two data acquisitions, one with a global inversion prepulse followed by one with a slice selective prepulse (FAIR). The prepulses lead to a labeling of blood water spins. In contrast to the global inversion prepulse, the slice selective inversion prepulse only labels the blood water spins inside the kidney but not the inflowing blood water spins. Subtraction of both images therefore reflects the local perfusion. A third image without the FAIR preparation pulse is measured to normalize the signal intensifiers on each patients.

MRI based arterial spin labeling is a noninvasive assessment not using contrast agents to measure the functional parameters of the kidney. This is avoiding serious complications such as acute kidney failure and nephrogenic systemic fibrosis. There is no known negative impact to the patient. In addition we now want to analyze the validity of this MRI‐technique by provoking acutely changes of renal plasma flow. As a further provocative maneuver we selected the cold pressor test as a physiological stress test. Forehead cooling activates the sympathetic nervous system and increases blood pressure and heart rate by causing pain. This mechanism has got an impact on renal haemodynamics. To minimize the possible cold injuries we use the 1°C ice water pack only for 60 seconds and avoid the contact to the eyes.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hypertension
  • Chronic Kidney Disease
Intervention  ICMJE Other: renal perfusion
measurement of renal perfusion with MRI arterial spin labelling technique
Study Arms  ICMJE
  • Experimental: 1.5 Tesla MRI
    Measurement of renal perfusion by 1.5 Tesla MRI with arterial spin labelling
    Intervention: Other: renal perfusion
  • Experimental: 3.0 Tesla MRI
    Measurement of renal perfusion by 3.0 Tesla MRI with arterial spin labelling
    Intervention: Other: renal perfusion
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02746549
Other Study ID Numbers  ICMJE MRT2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland E. Schmieder, MD University of Erlangen-Nürnberg
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP