Renal InfarctionNCT03474250
Trans-aortic Valve Replacement and Renal Infarction
An observational study of Renal Infarction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Infarction
- What is being tested?
- Magnetic Resonance test for kidney
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2018to 31 Dec 2018
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that will be undergoing trans-cather aortic valve replacement for severe symptomatic aortic stenosis
Who may be able to join
- Severe symptomatic aortic stenosis
- Patient is able to lay down supine for 20 min (the time needed to perform the MRI) without any difficulties.
Who cannot join
- Patient is on chronic renal replacement therapy (Dialysis)
- Documented Thrombus in the left ventricle or left atria
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Arwa Younis, Doctor
About this study
Official title: Trans-catheter Aortic Valve Replacement and Renal Infarction Among Patients With Severe Aortic Stenosis
Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement
Read the detailed description
Each patient will undergo Magnetic Resonance assessment of the kidneys before the TAVR. on the third to 7th day after the ATVR, a second MRI to the kidneys will be performed. we will assess the changes and new lesions between both MRI tests and will perform a qualitative and quantitative measurement.
- Conditions
- Renal Infarction
- Being tested
- Magnetic Resonance test for kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance test for kidneyDiagnostic test
Magnetic Resonance test for kidney
What is being measured
The primary outcome is the main question the study is designed to answer.
New Renal Infarction
New low signal intensity lesions on diffusion weighted images on MRI.
Measured: one year
Secondary outcomes (4)
Hematuria
New hematuria on urine test.
Measured: one year
Elevation in Blood Pressure
Delta of more than 5%
Measured: one year
Elevation in Plasma Renin Activity
Delta of more than 5%
Measured: one year
Elevation in Aldosteron level
Delta of more than 5%
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InfarctionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Amit Segev, Sheba Medical Center
- Investigators
- Arwa Younis, Doctor, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474250
- Sponsor's protocol ID
- 4887-18
- Status last verified
- Apr 2018
- First submitted
- 22 Feb 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-catheter Aortic Valve Replacement and Renal Infarction Among Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03474250
- Acronym / sponsor ID
- 4887-18
- Conditions
- Renal Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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.
Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement
Detailed description
Each patient will undergo Magnetic Resonance assessment of the kidneys before the TAVR. on the third to 7th day after the ATVR, a second MRI to the kidneys will be performed. we will assess the changes and new lesions between both MRI tests and will perform a qualitative and quantitative measurement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that will be undergoing trans-cather aortic valve replacement for severe symptomatic aortic stenosis
Key inclusion criteria (2 listed)
- Severe symptomatic aortic stenosis
- Patient is able to lay down supine for 20 min (the time needed to perform the MRI) without any difficulties.
Key exclusion criteria (2 listed)
- Patient is on chronic renal replacement therapy (Dialysis)
- Documented Thrombus in the left ventricle or left atria
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 |
|---|---|---|
| Magnetic Resonance test for kidneyMagnetic Resonance test for kidney | Diagnostic test | – |
Primary outcome
New Renal Infarction
Time frame: one year
New low signal intensity lesions on diffusion weighted images on MRI.
4 secondary outcomes
Hematuria
Time frame: one year
Elevation in Blood Pressure
Time frame: one year
Elevation in Plasma Renin Activity
Time frame: one year
Elevation in Aldosteron level
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Arwa Younis, Doctor principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Infarction, run by Sheba Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 1 May 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arwa Younis, Doctor (0544731936, or.younis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Renal Infarction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2018.