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

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ClinicalTrials.gov Identifier: NCT02746549
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.


Condition or disease Intervention/treatment Phase
Hypertension Chronic Kidney Disease Other: renal perfusion Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: 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).
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: 1.5 Tesla MRI
Measurement of renal perfusion by 1.5 Tesla MRI with arterial spin labelling
Other: renal perfusion
measurement of renal perfusion with MRI arterial spin labelling technique
Experimental: 3.0 Tesla MRI
Measurement of renal perfusion by 3.0 Tesla MRI with arterial spin labelling
Other: renal perfusion
measurement of renal perfusion with MRI arterial spin labelling technique



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746549


Contacts
Contact: Dennis Kannenkeril, MD +49-9131-85 ext 36245 dennis.kannenkeril@uk-erlangen.de
Contact: Roland E. Schmieder, MD +49-9131-85 ext 36245 roland.schmieder@uk-erlangen.de

Locations
Germany
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Recruiting
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Roland E. Schmieder, MD University of Erlangen-Nürnberg

Publications:
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02746549     History of Changes
Other Study ID Numbers: MRT2014
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency