Hypertension Clinical Trial
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).
NCT number | NCT02746549 |
Other study ID # | MRT2014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | March 2019 |
Verified date | March 2020 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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