HypertensionNCT02746549
Accuracy of 1.5 T Versus 3 T Magnetic Resonance Arterial Spin Labeling to Measure Renal Blood Flow
A study testing renal perfusion in people with Hypertension and Chronic Kidney Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Chronic Kidney Disease
- What is being tested?
- renal perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Implanted cardiac pacemaker, pacemaker wires or defibrillator
- Prosthetic heart valves
- Cochlear implant
- Ocular foreign body
- Implanted insulin pump,
- Tattoo (as determined by imager)
- agoraphobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, 91054
About this study
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).
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.
Read the 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).
- Conditions
- Hypertension, Chronic Kidney Disease
- Being tested
- renal perfusion
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal perfusionOther
measurement of renal perfusion with MRI arterial spin labelling technique
| Study group | Role | What they receive |
|---|---|---|
| 1.5 Tesla MRI | Experimental | Measurement of renal perfusion by 1.5 Tesla MRI with arterial spin labelling Receives: Other: renal perfusion |
| 3.0 Tesla MRI | Experimental | Measurement of renal perfusion by 3.0 Tesla MRI with arterial spin labelling Receives: Other: renal perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E. Schmieder, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746549
- Sponsor's protocol ID
- MRT2014
- Status last verified
- Mar 2020
- First submitted
- 8 Oct 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26986143
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02746549
- Acronym / sponsor ID
- MRT2014
- Conditions
- Hypertension, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5 Tesla MRI | Experimental | Other: renal perfusionMeasurement of renal perfusion by 1.5 Tesla MRI with arterial spin labelling |
| 3.0 Tesla MRI | Experimental | Other: renal perfusionMeasurement of renal perfusion by 3.0 Tesla MRI with arterial spin labelling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal perfusionmeasurement of renal perfusion with MRI arterial spin labelling technique | Other | 1.5 Tesla MRI, 3.0 Tesla MRI |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 26986143Hammon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland E. Schmieder, MD principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal perfusion in people with Hypertension and Chronic Kidney Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of 1.5 T versus 3 T magnetic resonance arterial spin labeling to measure renal perfusion (ml/min) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.