Triggers of Acute Ischemic Stroke Due to Large Vessel OcclusionNCT06265155
Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion
An observational study of Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion, run by Anzhi Li at 1 site in China.
Trial summary
Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with ischemic stroke due to large vessel occlusion。
Who may be able to join
- age ≥ 18 years
- imaging diagnosis of large vessel occlusion
- CT excluded intracranial hemorrhage
- signed informed consent form by the patient himself or his legal representative
Who cannot join
- severe bleeding or known significant bleeding tendency
- severe organ dysfunction
- life expectancy of less than 90 days
- presence of other conditions that the investigator considers inappropriate for enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion: A Case-crossover Study
Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke.
Read the detailed description
Stroke has a high lifetime risk worldwide and its morbidity and mortality are high. Among them, acute ischemic stroke caused by large vessel occlusion has serious condition and poor prognosis, which brings serious medical burden to individuals, families and society. Ischemic stroke includes various causes of cerebral blood supply disorders, leading to local brain ischemia, hypoxic necrosis, and rapid onset of corresponding neurological deficit symptoms. Its etiology includes vascular wall lesions, heart disease and hemodynamic changes, blood composition and hemorheological changes. Identified long-term risk factors for acute ischemic stroke include advanced age, male sex, race, hypertension, hypercholesterolemia, diabetes, smoking, sleep apnea, hyperhomocysteinemia, lifestyle, etc. Most of these risk factors are involved only in the development of acute ischemic stroke disease and do not directly contribute to the development of acute ischemic stroke.
The investigators aim was to gain insight into potential triggers in patients with acute ischemic stroke caused by large vessel occlusion in the short term before onset, and this trial intends to scientifically evaluate exposure to a range of potential triggers, including infection, extreme temperature changes, and several factors that increase blood pressure and their short-term risk of ischemic stroke through a multicenter, case-crossover study. Case-crossover study design is an epidemiological method used to investigate the instantaneous effects of transient exposure on acute illness, which has been widely used in heart disease, injury, car accidents and other research. The advantage of this method is that the use of the case itself as a control not only avoids the bias caused by the selection of the control, but also avoids the bias caused by some uncontrollable factors (such as age intelligence, genetics, etc.) between the cases. Exposure during the preictal risk period (exposure observed during the risk period) was asked about exposure to each trigger in the year preceding the onset of acute ischemic stroke. To assess the relative risk (RR) of ischemic stroke resulting from exposure to triggers and compare exposure during the risk period with the usual frequency of exposure. Exposure in the past year and mean exposure in the past year (assessed as chronic risk factors) and time to last exposure (assessed as triggers), estimated relative risks (RRs) and corresponding 95% CIs, assessed short-term risk of acute ischemic stroke due to large vessel occlusion by multiple triggers.
Previous studies of acute ischemic stroke triggers have found that negative mood, anger, and sudden changes in body posture in response to startle events appear to be independent triggers of ischemic stroke, and infectious syndromes may also be associated with an increased risk of stroke. Hemorrhagic stroke can be triggered by several triggers associated with acute, short-term blood pressure surges, including caffeine intake, minor head trauma, sexual activity, straining to defecate, lifting weights, strenuous physical exercise, fever, and flu-like illness. In addition, the triggers of intracranial aneurysm rupture and stroke in young adults have also been further clarified. Several possible biological explanations exist for how triggers increase stroke risk. First, some triggers, such as caffeine intake, certain types of drugs, sexual activity, and strenuous physical exercise, briefly raise blood pressure. Elevated blood pressure may lead to increased shear stress on the arterial vessel wall, potentially leading to disruption of the endothelial cell surface, which may increase the risk of thrombotic occlusion, particularly in combination with hypercoagulability caused by intense physical exercise. Therefore, an in-depth understanding of the potential triggers of acute ischemic stroke resulting from large vessel occlusion may not only improve the understanding of the pathophysiology of acute ischemic stroke, but may also provide new insights into its prevention and diagnosis and treatment methods.
- Keywords
- Stroke, Trigger, Acute ischaemic stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
RR values for exposure during the risk period versus exposure in the past year for each trigger
RR values for exposure during the risk period versus exposure in the past year for each trigger
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Feb 2024
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triggers of Acute Ischemic Stroke Due to Large Vessel OcclusionStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anzhi Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anzhi Li, Suzhou Municipal Hospital of Anhui Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265155
- Sponsor's protocol ID
- SuzhouMHAnhui
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion: A Case-crossover Study
- ClinicalTrials.gov ID
- NCT06265155
- Acronym / sponsor ID
- SuzhouMHAnhui
- Keywords
- Stroke, Trigger, Acute ischaemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Anzhi LiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Feb 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.
Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke.
Detailed description
Stroke has a high lifetime risk worldwide and its morbidity and mortality are high. Among them, acute ischemic stroke caused by large vessel occlusion has serious condition and poor prognosis, which brings serious medical burden to individuals, families and society. Ischemic stroke includes various causes of cerebral blood supply disorders, leading to local brain ischemia, hypoxic necrosis, and rapid onset of corresponding neurological deficit symptoms. Its etiology includes vascular wall lesions, heart disease and hemodynamic changes, blood composition and hemorheological changes. Identified long-term risk factors for acute ischemic stroke include advanced age, male sex, race, hypertension, hypercholesterolemia, diabetes, smoking, sleep apnea, hyperhomocysteinemia, lifestyle, etc. Most of these risk factors are involved only in the development of acute ischemic stroke disease and do not directly contribute to the development of acute ischemic stroke.
The investigators aim was to gain insight into potential triggers in patients with acute ischemic stroke caused by large vessel occlusion in the short term before onset, and this trial intends to scientifically evaluate exposure to a range of potential triggers, including infection, extreme temperature changes, and several factors that increase blood pressure and their short-term risk of ischemic stroke through a multicenter, case-crossover study. Case-crossover study design is an epidemiological method used to investigate the instantaneous effects of transient exposure on acute illness, which has been widely used in heart disease, injury, car accidents and other research. The advantage of this method is that the use of the case itself as a control not only avoids the bias caused by the selection of the control, but also avoids the bias caused by some uncontrollable factors (such as age intelligence, genetics, etc.) between the cases. Exposure during the preictal risk period (exposure observed during the risk period) was asked about exposure to each trigger in the year preceding the onset of acute ischemic stroke. To assess the relative risk (RR) of ischemic stroke resulting from exposure to triggers and compare exposure during the risk period with the usual frequency of exposure. Exposure in the past year and mean exposure in the past year (assessed as chronic risk factors) and time to last exposure (assessed as triggers), estimated relative risks (RRs) and corresponding 95% CIs, assessed short-term risk of acute ischemic stroke due to large vessel occlusion by multiple triggers.
Previous studies of acute ischemic stroke triggers have found that negative mood, anger, and sudden changes in body posture in response to startle events appear to be independent triggers of ischemic stroke, and infectious syndromes may also be associated with an increased risk of stroke. Hemorrhagic stroke can be triggered by several triggers associated with acute, short-term blood pressure surges, including caffeine intake, minor head trauma, sexual activity, straining to defecate, lifting weights, strenuous physical exercise, fever, and flu-like illness. In addition, the triggers of intracranial aneurysm rupture and stroke in young adults have also been further clarified. Several possible biological explanations exist for how triggers increase stroke risk. First, some triggers, such as caffeine intake, certain types of drugs, sexual activity, and strenuous physical exercise, briefly raise blood pressure. Elevated blood pressure may lead to increased shear stress on the arterial vessel wall, potentially leading to disruption of the endothelial cell surface, which may increase the risk of thrombotic occlusion, particularly in combination with hypercoagulability caused by intense physical exercise. Therefore, an in-depth understanding of the potential triggers of acute ischemic stroke resulting from large vessel occlusion may not only improve the understanding of the pathophysiology of acute ischemic stroke, but may also provide new insights into its prevention and diagnosis and treatment methods.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ischemic stroke due to large vessel occlusion。
Key inclusion criteria (4 listed)
- age ≥ 18 years
- imaging diagnosis of large vessel occlusion
- CT excluded intracranial hemorrhage
- signed informed consent form by the patient himself or his legal representative
Key exclusion criteria (4 listed)
- severe bleeding or known significant bleeding tendency
- severe organ dysfunction
- life expectancy of less than 90 days
- presence of other conditions that the investigator considers inappropriate for enrollment
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
RR values for exposure during the risk period versus exposure in the past year for each trigger
Time frame: up to 24 hours
RR values for exposure during the risk period versus exposure in the past year for each trigger
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 23 Jun 2026.
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.
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 Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion, run by Anzhi Li 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 4 inclusion and 4 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 23 Jun 2026. 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?
RR values for exposure during the risk period versus exposure in the past year for each trigger (time frame: up to 24 hours). 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 23 Jun 2026.