Focus of Study is MRIMRAtSLIPNCT02032940
Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique
An observational study of Focus of Study is MRI, run by Miami Cardiac and Vascular Institute at 2 sites in United States.
Trial summary
The purpose of the study is to create MR images using an investigative technique called pulse sequences with new computer software programs. The sequence will allow us to image vessels without injecting contrast agents. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is MRI
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Apr 2020
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All Patients Needing Thoracic, Aortic, Renal, Iliac and/or Femoral Vasculature MRIs
Who may be able to join
- All patients that are considered candidates and scheduled for standard contrast enhanced MRA can be included in the study.
Who cannot join
- Patients that can not undergo standard MRA
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Miami Cardiac and Vascular Institute
Miami, Florida, 33176
About this study
The purpose of the study is to create MR images using an investigative technique called pulse sequences with new computer software programs. The sequence will allow us to image vessels without injecting contrast agents.
Read the detailed description
The t-SLIP Investigational Study Sequences are designed to compare t-SLIP to standard MR contrast enhanced imaging techniques to establish the diagnosic benefits of t-SLIP compared to contrast enhanced MR techniques. The t-SLIP Investigational Study Sequences will be used for vascular MRI Imaging including, but no limited to, MRA of the renal, mesenteric, abdominal aortic, iliac and femoral arteries. We will be targeting all adult patients undergoing standard body MRA examinations without anesthesia.
The time spatial labeling inversion pulse (t-SLIP) technique is used for non contrast enhanced MR angiography imaging. It produces bright blood spin labeling images by using a single acquisition with a combination of a spatially nonselective inversion pulse and a spatially selective inversion pulse. The nonselective pulse inverts the magnetization of the entire imaging area. The spatially selective pulse, applied upstream of the arteries of interest, reverts those protons to full magnetization. A pre defined time delay between tagging and imaging allows the tagged spins to reach the imaging region and suppresses background tissue within the imaging region to some extent.
- Conditions
- Focus of Study is MRI
- Keywords
- MRI, Angiography, Pulse Sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard Sequence Imaging MRI | Patients requiring MRI. All Comers accepting study participation. | |
| Additional Pulse Sequence Increased | Patients requiring MRI. All comers accepting study participation and the run of additional pulse sequences during MRI procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of enhancement by evaluation of the Thoracic, Aortic, Renal, Iliac and Femoral Vasculature Images
The project proposal is to acquire the additional sequence as part of the standard examination and then to compare the sequence to the standard MR contrast enhanced imaging techniques in order to establish the diagnostic benefits of this sequence compared to contrast enhanced MR techniques.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study is MRIStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami Cardiac and Vascular Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantino Pena, MD, Miami Cardiac and Vascular Institute
- Investigators
- Constantino Pena, MD, Principal investigator, Baptist Cardiac and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032940
- Sponsor's protocol ID
- 2013-020
- Acronym
- MRAtSLIP
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2014
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique
- ClinicalTrials.gov ID
- NCT02032940
- Acronym / sponsor ID
- MRAtSLIP / 2013-020
- Conditions
- Focus of Study is MRI
- Keywords
- MRI, Angiography, Pulse Sequence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Miami Cardiac and Vascular InstituteUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 10 Jan 2014 (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.
The purpose of the study is to create MR images using an investigative technique called pulse sequences with new computer software programs. The sequence will allow us to image vessels without injecting contrast agents.
Detailed description
The t-SLIP Investigational Study Sequences are designed to compare t-SLIP to standard MR contrast enhanced imaging techniques to establish the diagnosic benefits of t-SLIP compared to contrast enhanced MR techniques. The t-SLIP Investigational Study Sequences will be used for vascular MRI Imaging including, but no limited to, MRA of the renal, mesenteric, abdominal aortic, iliac and femoral arteries. We will be targeting all adult patients undergoing standard body MRA examinations without anesthesia.
The time spatial labeling inversion pulse (t-SLIP) technique is used for non contrast enhanced MR angiography imaging. It produces bright blood spin labeling images by using a single acquisition with a combination of a spatially nonselective inversion pulse and a spatially selective inversion pulse. The nonselective pulse inverts the magnetization of the entire imaging area. The spatially selective pulse, applied upstream of the arteries of interest, reverts those protons to full magnetization. A pre defined time delay between tagging and imaging allows the tagged spins to reach the imaging region and suppresses background tissue within the imaging region to some extent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Sequence Imaging MRI | – | –Patients requiring MRI. All Comers accepting study participation. |
| Additional Pulse Sequence Increased | – | –Patients requiring MRI. All comers accepting study participation and the run of additional pulse sequences during MRI procedure. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients Needing Thoracic, Aortic, Renal, Iliac and/or Femoral Vasculature MRIs
Key inclusion criteria (1 listed)
- All patients that are considered candidates and scheduled for standard contrast enhanced MRA can be included in the study.
Key exclusion criteria (1 listed)
- Patients that can not undergo standard MRA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of enhancement by evaluation of the Thoracic, Aortic, Renal, Iliac and Femoral Vasculature Images
Time frame: 2 Years
The project proposal is to acquire the additional sequence as part of the standard examination and then to compare the sequence to the standard MR contrast enhanced imaging techniques in order to establish the diagnostic benefits of this sequence compared to contrast enhanced MR techniques.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Constantino Pena, MD principal investigator
Baptist Cardiac and Vascular Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study is MRI, run by Miami Cardiac and Vascular Institute at 2 sites in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Degree of enhancement by evaluation of the Thoracic, Aortic, Renal, Iliac and Femoral Vasculature Images (time frame: 2 Years). 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 3 Apr 2023.