Stroke, Acute IschemicTRACK-LVO-2NCT05659160
Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2
An observational study of Stroke, Acute Ischemic and Endovascular Procedures, run by Tianjin Huanhu Hospital at 4 sites in China.
Trial summary
The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic, Endovascular Procedures, Large Vessel Occlusion
- What is being tested?
- Endovascular Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2021to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All acute ischemic stroke patients with large vessel occlusion.
Who may be able to join
- Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
- Age ≥ 18;
- Ischemic stroke confirmed by head CT or MRI;
- Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
- Patients receiving either endovascular therapy or best medical treatment;
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Xuanye Yue, MD, 022-60814622, yuexy2002@aliyun.com
Xuanye Yue, MD
- Recruiting
The Sencond Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Zhenjian Ma, MD, 18322412226, mazhenjian@126.com
Zhenjian Ma, MD
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300222
Ming Wei, MD, PhD, 13502182903, drweiming@163.com
Ming Wei, MD, PhD
- Recruiting
Beijing University Binhai Hospital
Tianjin, Tianjin Municipality, 300450
Wanchao Shi, MD, 15620177339, swc9801@sina.com
Wanchao Shi, MD
About this study
Official title: Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2 (TRACK-LVO-2): an Imaging-based Patient Registry Study
The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Read the detailed description
The TRACK-LVO registry is an observational study conducted across multiple centers with the aim of improving the detection and treatment of large vessel occlusion (LVO) in acute ischemic stroke (AIS) patients. LVO is a major predictor of unfavorable outcomes in stroke patients, and the most effective imaging modalities for its detection remain a topic of debate.
To address this, the investigators will enroll consecutive AIS patients with LVO screened under different imaging modalities and compared the efficacy of endovascular therapy (EVT) and best medical management (BMM). The registry defines LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA. Patient information, including basic demographic profiles, imaging characteristics such as volume of ischemic core and occlusion site, and treatment-related complications will be collected for both EVT and BMM groups. For patients in the EVT group, detailed information on the EVT procedure and angiographic images will also be collected.
The study aims to identify the optimal imaging modalities for LVO detection and to compare the prognosis of AIS patients with LVO receiving EVT versus BMM. This academic, real-world, multi-center, observational registry will contribute valuable insights to improve the detection and treatment of LVO in AIS patients, ultimately improving patient outcomes and reducing the burden of stroke on public health and socio-economic development.
- Being tested
- Endovascular Therapy
- Keywords
- Acute Ischemic Stroke, Endovascular Therapy, Large Vessel Occlusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TherapyProcedure or surgery
Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging.
Endovascular therapy includes any one or more of the following:
Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods. Receives: Procedure: Endovascular Therapy | |
| Best medical management | Patients enrolled in this group received the best medical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified ranking scale (mRS) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
Measured: 90 days
Mortality within 90 days
mortality of any causes.
Measured: 90 days
Secondary outcomes (4)
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: 90 days
Occurrence of periprocedural complications
Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.
Measured: 14 days postoperatively
ASPECT (Alberta Stroke Program Early CT score)
ASPECTS is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery (MCA) stroke.
Measured: Day 0
EuroQol five dimensions questionnaire (EQ-5D)
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies 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
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659160
- Sponsor's protocol ID
- TJHH-2022-WM12
- Acronym
- TRACK-LVO-2
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2022
- Last updated
- 1 Dec 2023
- 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 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2 (TRACK-LVO-2): an Imaging-based Patient Registry Study
- ClinicalTrials.gov ID
- NCT05659160
- Acronym / sponsor ID
- TRACK-LVO-2 / TJHH-2022-WM12
- Keywords
- Acute Ischemic Stroke, Endovascular Therapy, Large Vessel Occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Dec 2022 (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 of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Detailed description
The TRACK-LVO registry is an observational study conducted across multiple centers with the aim of improving the detection and treatment of large vessel occlusion (LVO) in acute ischemic stroke (AIS) patients. LVO is a major predictor of unfavorable outcomes in stroke patients, and the most effective imaging modalities for its detection remain a topic of debate.
To address this, the investigators will enroll consecutive AIS patients with LVO screened under different imaging modalities and compared the efficacy of endovascular therapy (EVT) and best medical management (BMM). The registry defines LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA. Patient information, including basic demographic profiles, imaging characteristics such as volume of ischemic core and occlusion site, and treatment-related complications will be collected for both EVT and BMM groups. For patients in the EVT group, detailed information on the EVT procedure and angiographic images will also be collected.
The study aims to identify the optimal imaging modalities for LVO detection and to compare the prognosis of AIS patients with LVO receiving EVT versus BMM. This academic, real-world, multi-center, observational registry will contribute valuable insights to improve the detection and treatment of LVO in AIS patients, ultimately improving patient outcomes and reducing the burden of stroke on public health and socio-economic development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | – | Procedure: Endovascular TherapyTimely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods. |
| Best medical management | – | –Patients enrolled in this group received the best medical management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All acute ischemic stroke patients with large vessel occlusion.
Key inclusion criteria (5 listed)
- Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
- Age ≥ 18;
- Ischemic stroke confirmed by head CT or MRI;
- Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
- Patients receiving either endovascular therapy or best medical treatment;
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Endovascular TherapyEndovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices. | Procedure or surgery | Endovascular therapy |
Primary outcome
Modified ranking scale (mRS) at 90 days
Time frame: 90 days
A 0-6 scale running from perfect health without symptoms to death.
Mortality within 90 days
Time frame: 90 days
mortality of any causes.
4 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
Time frame: 90 days
Occurrence of periprocedural complications
Time frame: 14 days postoperatively
ASPECT (Alberta Stroke Program Early CT score)
Time frame: Day 0
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke, Acute Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute Ischemic and Endovascular Procedures, run by Tianjin Huanhu Hospital at 4 sites 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 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: looking for participants now, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Wei, PhD (13502182903, drweiming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified ranking scale (mRS) at 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. 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 Dec 2023.