Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch)NCT06213870
Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke
An observational study of Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch) and Image Evaluation, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the role of MRI evaluation based on FVH-DWI mismatch principle in preoperative evaluation of endovascular thrombolectomy. The main questions it aims to answer are: The consistency between MRI and perfusion examination in determining EVT indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch), Image Evaluation, Endovascular Thrombectomy
- What is being tested?
- Surgical criteria
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Nov 2023
- 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: Patients were recruited in Tianjin Huanhu hospital in China between August 1, 2022, and Augut 1, 2023.
Who may be able to join
- (1) age ≥ 18 years old;
- (2) symptoms consistent with acute ischemic stroke and an onset time of 6-24h;
- (3) CT ASPECTS score≥6 points;NIHSS≥6points; modified Rankin scale (mRS) of 0-2 points prior to stroke;
- (4) internal carotid artery (ICA) and/or M1 segment of middle cerebral artery (MCA-M1) and M2 proximal segment occlusion with definite diagnosis.
- (5)agree to comply with the protocol follow-up requirements.
Who cannot join
- (1)Image unanalyzable.
- (2)3 months follow-up was not completed
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about the role of MRI evaluation based on FVH-DWI mismatch principle in preoperative evaluation of endovascular thrombolectomy.
The main questions it aims to answer are:
- The consistency between MRI and perfusion examination in determining EVT indications.
- The consistency of functional independence rate between patients screening with MRI and perfusion.
Read the detailed description
MRI is the preferred imaging mode in many centers,for the diffusion-weighted imaging (DWI) sequences are highly sensitive to acute cerebral ischemia.In addition, MRI does not require intravenous contrast agent, which is simpler and more popular than perfusion.Fluid-attenuated inversion recovery (FLAIR)sequence vascular hyperintensity(FVH) is defined as focal, serpentine, or linear hyperintensity that usually occurs in the Sylvian fissure and is associated with large-vessel occlusion or stenosis.The FVH-DWI mismatch(defined as the FVH extended beyond the boundary of the DWI cortical lesions) had been confirmed has excellent sensitivity and specificity in predicting PWI-DWI mismatch.It is not well established whether MRI based on FVH-DWI mismatch and perfusion evaluation differ in determining EVT indications and outcomes.
The main objectives of this study were to (1) determine the proportion of patients eligible for EVT surgery selected by MRI based on FVH-DWI mismatch vs perfusion in a large multicenter registry and (2) identify statistical differences in functional outcomes and safety outcomes between the two evaluation methods.
Patients with ischemic stroke with anterior-circulation large-vessel occlusion in the late (6-24 h) time window from real-world, single center retrospective cohort registry were compared.In the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were otherwise treated with medication.In the perfusion group, surgical indications referring the DEFUSE 3 standards. The primary outcome was 90-day functional independence rate (mRS score ≤2) in all patients included(including EVT patient and medication patients).Safety outcomes included symptomatic intracranial hemorrhage (sICH), and 90-day mortality.
- Conditions
- Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch), Image Evaluation, Endovascular Thrombectomy
- Being tested
- Surgical criteria
- Keywords
- FVH-DWI mismatch;Endovascular Thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical criteriaDiagnostic test
In the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were otherwise treated with medication.
In the perfusion group, patients who meet the criteria of DEFUSE3 will receive EVT surgery, otherwise receive medication.
| Study group | Role | What they receive |
|---|---|---|
| MRI group | MRI Images were acquired on a 3T Siemens Prisma scanner (Siemens AG, Munich, Germany).Image sequences and typical parameter ranges were diffusion tensor imaging (repetition time [TR], 5200ms; echo time [TE], 80 ms; 4mm slice thickness; 40 slices) by using SE-EPI sequence; T1 imaging (TR, 240 ms; TE, 2.47 ms; 5 mm slice thickness; 17 slices) by using SE sequence;T2 imaging (TR, 4480 ms; TE, 99 ms; 4 mm slice thickness; 24 slices) by using FSE sequence; FLAIR imaging (TR, 8500 ms; TE, 95 ms; 5 mm slice thickness; 21 slices) by using IR sequence; time-of-flight magnetic resonance angiography images (TR, 20 ms; TE, 3 ms; 0.55 mm slice thickness; 40 slices) by using 3D-TOF sequence;
In the MRI group, patients with FVH-DWI mismatch were considered to have EVT indications and were treated with EVT, while patients without FVH-DWI mismatch were treated with medication. Receives: Diagnostic Test: Surgical criteria | |
| Perfusion group | The protocol of CT Perfusion was as follows: 100 mm coverage in the z-axis, tube voltage, 80 kV; tube current, 120 mA; section thickness, 5 mm. Twenty-four consecutive spiral acquisitions with 0.28 seconds of rotation time and 1.70 seconds of inter scan delay time were performed.
Patients in the perfusion group were treated with EVT when there exist perfusion mismatch(defined as regional cerebral blood flow (<30%) was < 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml), and were treated with medication when there was no perfusion mismatch. Receives: Diagnostic Test: Surgical criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day functional independence rate
Proportion of patients with mRS0-2 scores at 90 days
Measured: 90days
Secondary outcomes (1)
symptomatic intracranial hemorrhage
according to the definition proposed by European Cooperative Acute Stroke Study III: intracranial hemorrhage that is associated with deterioration in NIHSS of 4 or more points and the main reason for neurological deterioration
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch)Studies 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
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
- Investigators
- Ming Wei, PhD, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213870
- Sponsor's protocol ID
- TJHH-2023-WM51
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06213870
- Acronym / sponsor ID
- TJHH-2023-WM51
- Conditions
- Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch), Image Evaluation, Endovascular Thrombectomy
- Keywords
- FVH-DWI mismatch;Endovascular Thrombectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 19 Jan 2024 (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 goal of this observational study is to learn about the role of MRI evaluation based on FVH-DWI mismatch principle in preoperative evaluation of endovascular thrombolectomy.
The main questions it aims to answer are:
- The consistency between MRI and perfusion examination in determining EVT indications.
- The consistency of functional independence rate between patients screening with MRI and perfusion.
Detailed description
MRI is the preferred imaging mode in many centers,for the diffusion-weighted imaging (DWI) sequences are highly sensitive to acute cerebral ischemia.In addition, MRI does not require intravenous contrast agent, which is simpler and more popular than perfusion.Fluid-attenuated inversion recovery (FLAIR)sequence vascular hyperintensity(FVH) is defined as focal, serpentine, or linear hyperintensity that usually occurs in the Sylvian fissure and is associated with large-vessel occlusion or stenosis.The FVH-DWI mismatch(defined as the FVH extended beyond the boundary of the DWI cortical lesions) had been confirmed has excellent sensitivity and specificity in predicting PWI-DWI mismatch.It is not well established whether MRI based on FVH-DWI mismatch and perfusion evaluation differ in determining EVT indications and outcomes.
The main objectives of this study were to (1) determine the proportion of patients eligible for EVT surgery selected by MRI based on FVH-DWI mismatch vs perfusion in a large multicenter registry and (2) identify statistical differences in functional outcomes and safety outcomes between the two evaluation methods.
Patients with ischemic stroke with anterior-circulation large-vessel occlusion in the late (6-24 h) time window from real-world, single center retrospective cohort registry were compared.In the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were otherwise treated with medication.In the perfusion group, surgical indications referring the DEFUSE 3 standards. The primary outcome was 90-day functional independence rate (mRS score ≤2) in all patients included(including EVT patient and medication patients).Safety outcomes included symptomatic intracranial hemorrhage (sICH), and 90-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI group | – | Diagnostic Test: Surgical criteriaMRI Images were acquired on a 3T Siemens Prisma scanner (Siemens AG, Munich, Germany).Image sequences and typical parameter ranges were diffusion tensor imaging (repetition time [TR], 5200ms; echo time [TE], 80 ms; 4mm slice thickness; 40 slices) by using SE-EPI sequence; T1 imaging (TR, 240 ms; TE, 2.47 ms; 5 mm slice thickness; 17 slices) by using SE sequence;T2 imaging (TR, 4480 ms; TE, 99 ms; 4 mm slice thickness; 24 slices) by using FSE sequence; FLAIR imaging (TR, 8500 ms; TE, 95 ms; 5 mm slice thickness; 21 slices) by using IR sequence; time-of-flight magnetic resonance angiography images (TR, 20 ms; TE, 3 ms; 0.55 mm slice thickness; 40 slices) by using 3D-TOF sequence; In the MRI group, patients with FVH-DWI mismatch were considered to have EVT indications and were treated with EVT, while patients without FVH-DWI mismatch were treated with medication. |
| Perfusion group | – | Diagnostic Test: Surgical criteriaThe protocol of CT Perfusion was as follows: 100 mm coverage in the z-axis, tube voltage, 80 kV; tube current, 120 mA; section thickness, 5 mm. Twenty-four consecutive spiral acquisitions with 0.28 seconds of rotation time and 1.70 seconds of inter scan delay time were performed. Patients in the perfusion group were treated with EVT when there exist perfusion mismatch(defined as regional cerebral blood flow (<30%) was < 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml), and were treated with medication when there was no perfusion mismatch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited in Tianjin Huanhu hospital in China between August 1, 2022, and Augut 1, 2023.
Key inclusion criteria (5 listed)
- (1) age ≥ 18 years old;
- (2) symptoms consistent with acute ischemic stroke and an onset time of 6-24h;
- (3) CT ASPECTS score≥6 points;NIHSS≥6points; modified Rankin scale (mRS) of 0-2 points prior to stroke;
- (4) internal carotid artery (ICA) and/or M1 segment of middle cerebral artery (MCA-M1) and M2 proximal segment occlusion with definite diagnosis.
- (5)agree to comply with the protocol follow-up requirements.
Key exclusion criteria (2 listed)
- (1)Image unanalyzable.
- (2)3 months follow-up was not completed
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 |
|---|---|---|
| Surgical criteriaIn the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were otherwise treated with medication. In the perfusion group, patients who meet the criteria of DEFUSE3 will receive EVT surgery, otherwise receive medication. | Diagnostic test | MRI group, Perfusion group |
Primary outcome
90-day functional independence rate
Time frame: 90days
Proportion of patients with mRS0-2 scores at 90 days
1 secondary outcome
symptomatic intracranial hemorrhage
Time frame: 90days
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 19 Jan 2024.
- Individual participant dataSharing planned: Undecided
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.
Ming Wei, PhD principal investigator
Tianjin Huanhu Hospital
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 Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch) and Image Evaluation, run by Tianjin Huanhu Hospital at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 19 Jan 2024. 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 China. 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?
90-day functional independence rate (time frame: 90days). 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 19 Jan 2024.