StrokeNCT03971552
Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed
An observational study of Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- gadolinium-enhanced extracranial magnetic resonance angiogram
- Type of treatment
- Surgery or procedure
- How many people
- 912 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke (AIS) patients who underwent magnetic resonance imaging (MRI) based screening for acute neurovascular evaluation and who underwent mechanical thrombectomy (MT) at one comprehensive stroke center.
Who may be able to join
- Acute ischemic stroke
Who cannot join
None listed.
About this study
The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics.
Consecutive patients (912) treated by mechanical thrombectomy (MT) at a large comprehensive stroke center between January 2012 and December 2017 who were screened using pre-intervention MRI were included. Patient's characteristics and procedural data were collected. Analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial MRA.
- Conditions
- Stroke
- Being tested
- gadolinium-enhanced extracranial magnetic resonance angiogram
- Keywords
- Mechanical thrombectomy, Magnetic resonance angiography, Angiogram, Angiography, Magnetic resonance imaging, Revascularization
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadolinium-enhanced extracranial magnetic resonance angiogramProcedure or surgery
288 of the 912 acute ischemic stroke patients received gadolinium-enhanced extracranial MRA additionally to the standardized stroke MRI imaging protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
time from groin puncture to clot contact
in minute time from onset to recanalization complications [embolic or hemorrhagic]
Measured: 1 day
Secondary outcomes (1)
modified Rankin Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jan 2012
- Primary completion31 Dec 2017
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971552
- Sponsor's protocol ID
- 30687224
- Status last verified
- May 2019
- First submitted
- 26 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed
- ClinicalTrials.gov ID
- NCT03971552
- Acronym / sponsor ID
- 30687224
- Conditions
- Stroke
- Keywords
- Mechanical thrombectomy, Magnetic resonance angiography, Angiogram, Angiography, Magnetic resonance imaging, Revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 3 Jun 2019 (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.
The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics.
Consecutive patients (912) treated by mechanical thrombectomy (MT) at a large comprehensive stroke center between January 2012 and December 2017 who were screened using pre-intervention MRI were included. Patient's characteristics and procedural data were collected. Analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial MRA.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke (AIS) patients who underwent magnetic resonance imaging (MRI) based screening for acute neurovascular evaluation and who underwent mechanical thrombectomy (MT) at one comprehensive stroke center.
Key inclusion criteria (1 listed)
- Acute ischemic stroke
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gadolinium-enhanced extracranial magnetic resonance angiogram288 of the 912 acute ischemic stroke patients received gadolinium-enhanced extracranial MRA additionally to the standardized stroke MRI imaging protocol. | Procedure or surgery | – |
Primary outcome
time from groin puncture to clot contact
Time frame: 1 day
in minute time from onset to recanalization complications [embolic or hemorrhagic]
1 secondary outcome
modified Rankin Score
Time frame: 3 months
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 3 Jun 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 0 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
time from groin puncture to clot contact (time frame: 1 day). 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 Jun 2019.