MRINCT04481542
Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging
An observational study of MRI, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
We prospectively collected information on consecutive patients who had been evaluated using 4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020. Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- MRI
- What is being tested?
- MRI
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 12 Dec 2025
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with aortic disease
Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections. The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yao-Kuang Huang
Chiayi City, Chiayi County, 61362
Yao-Kuang Huang, 033186785, huang137@mac.com
About this study
We prospectively collected information on consecutive patients who had been evaluated using 4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020. Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections.
Read the detailed description
The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient was excluded due to fever at the scheduled time, and another was unable to lie down due to complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous administration of contrast media, followed by 4D PC-MRI to assess aortic pathology
- Conditions
- MRI
- Being tested
- MRI
- Keywords
- CVS MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
check MRI quality in aorta
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume
anatomic/hemodynamic parameter
Measured: 5 years
Secondary outcomes (1)
adverse event
diagnostic function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Mar 2018
- Primary completion12 Feb 2020
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481542
- Sponsor's protocol ID
- 2019011776B0
- Status last verified
- Mar 2020
- First submitted
- 23 Feb 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04481542
- Acronym / sponsor ID
- 2019011776B0
- Conditions
- MRI
- Keywords
- CVS MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 22 Jul 2020 (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.
We prospectively collected information on consecutive patients who had been evaluated using 4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020. Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections.
Detailed description
The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient was excluded due to fever at the scheduled time, and another was unable to lie down due to complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous administration of contrast media, followed by 4D PC-MRI to assess aortic pathology
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with aortic disease
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 |
|---|---|---|
| MRIcheck MRI quality in aorta | Diagnostic test | – |
Primary outcome
stroke volume
Time frame: 5 years
anatomic/hemodynamic parameter
1 secondary outcome
adverse event
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- 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.
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 MRI, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Jul 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume (time frame: 5 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 22 Jul 2020.