Stroke, AcuteCAIS-MTNCT06418698
The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy
An observational study of Stroke, Acute and Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
Trial summary
CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or medium vessel occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Ischemic Stroke, Vascular Diseases
- How many people
- 434 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to Jun 2029
- How long will I take part?
- 3 Years
- 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: Patients with a diagnosis of acute ischemic stroke due to large or medium vessel occlusion, who are enrolled at Zhujiang Hospital and meet the indication for EVT.
Who may be able to join
- Male or non-pregnant women with acute stroke symptoms aged over 18 years.
- Occlusion of the intracranial internal carotid artery, the middle cerebral artery, the anterior cerebral artery, the posterior cerebral artery, basilar artery and intracranial vertebral artery confirmed by CT, MR angiography, or digital subtraction angiography.
- No absolute contraindication to iodinated contrast media.
- Planned treatment with EVT by clinical care team.
- Informed consent obtained from patients or their legal representatives.
- Willing to be followed up as required by the clinical study protocol.
Who cannot join
- Acute ischemic stroke occurs over 24 hours of time last known well.
- Neurologic deficits caused by diagnoses other than ischemic stroke, such as intracerebral hemorrhage, subarachnoid hemorrhage, or intracranial tumors.
- With other underlying factors leading to IAC, such as hyperthyroidism, end-stage renal disease, long-term oral intake of vitamin K antagonist(Warfarin), chronic vitamin D deficiency or overdose, persistent hypomagnesemia, persistent hypercalcemia, persistent hyperphosphatemia and high oral calcium intake.
- Lack of non-contract CT images on admission and significant artifacts in CT images preventing IAC measurement.
- Severe renal insufficiency (estimated glomerular filtration rate < 30ml/min or serum creatinine > 220μmol/L (2.5mg/dl)).
- Previous cerebrovascular intervention treatment or craniotomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 528400
Feng Xin, MD, +8613681134001, 13681134001@163.com
Wen Zhuohua, MD, +8615622311746, 810107327@qq.com
About this study
Official title: The Prediction of Intracranial Artery Calcification on Adverse Outcomes of Large Vessel Occlusive, Acute Ischemic Stroke Patients After Mechanical Thrombectomy: A Prospective Cohort, Observational Study
CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or medium vessel occlusion.
Read the detailed description
This study have to objective to evaluate the predictive value of IAC Agatston score in patients with acute ischemic stroke due to large or medium vessel occlusion on worse angiographic and functional outcomes after EVT. The result of this study will provide a upfront basis for risk stratification of adverse outcomes of EVT by using quantitative IAC, so as to get a reference for an individualized and precise plan of EVT.
- Conditions
- Stroke, Acute, Ischemic Stroke, Vascular Diseases, Central Nervous System Diseases, Nervous System Diseases, Stroke
- Keywords
- Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Endovascular treatment, Agatston score, Prospective cohort study, Intracranial atherosclerotic disease
- Medical subject headings
- Stroke, Ischemic Stroke, Vascular Diseases, Central Nervous System Diseases, Nervous System Diseases, Brain Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute ischemic stroke due to large or medium vessel occlusion | Patients with acute ischemic stroke due to large or medium vessel occlusion meeting inclusion criteria, must accept mechanical thrombectomy and have CT images which can get the IAC Agatston score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a adverse functional outcome at 3 months
Modified Rankin Scale(mRS) score > 2
Measured: 90(±7) days
Secondary outcomes (18)
Proportion of patients without disability at 3 months
mRS score 0-1
Measured: 90(±7) days
Proportion of patients with functional independence at 3 months
mRS score 0-2
Measured: 90(±7) days
Proportion of patients ambulatory or bodily needs-capable or better at 3 months
mRS score 0-3
Measured: 90(±7) days
Change of the NIHSS score at 24 hours from baseline
Change of the NIHSS score at 24 hours from baseline
Measured: 24 hours
Change of the NIHSS score at 6 days or discharge if earlier from baseline
Change of the NIHSS score at 6 days or discharge if earlier from baseline
Measured: 6(±1) days
Health-related quality of life at 3 months
Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Measured: 90(±7) days
Proportion of substantial reperfusion at final angiogram
Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion)
Measured: 0 day
Proportion of substantial reperfusion at final angiogram without any rescue methods
Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion)
Measured: 0 day
Proportion of substantial reperfusion at first angiogram
Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion)
Measured: 0 day
Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours
ICH will be evaluated according to the Heidelberg Bleeding Classification. sICH is diagnosed if the new observed ICH is associated with any of the following conditions: 1) NIHSS score increased more than 4 points than that immediately before worsening; 2) NIHSS score increased more than 2 points in one category; 3) Deterioration led to intubation, hemicraniectomy, external ventricular drain placement or any other major interventions. Additionally, the symptom deteriorations could not be explained by causes other than the observed ICH.
Measured: Within 48 hours
Proportion of patients with any ICH within 48 hours
ICH will be evaluated according to the Heidelberg Bleeding Classification.
Measured: Within 48 hours
Mortality at 3 months
Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.
Measured: 90(±7) days
Incidence of serious adverse events
Including but not limited to acute respiratory failure, severe or malignant cerebral artery infarction, acute heart failure, debridement decompression, and other major medical events that can result in death, immediately life-threatening, hospitalization or prolongation of this hospitalization, terminally or severely disabling/incapacitating, the loss of a significant ability to maintain normal life functioning, or medical intervention to avoid the above outcomes.
Measured: Within 3 years
Procedure-related complications
such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation.
Measured: Up to 24 hours
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Measured: 365(±30) days
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Measured: 1095(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Measured: 365(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Measured: 1095(±30) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start28 Mar 2024
- Primary completion31 Dec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 434 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duan Chuanzhi, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418698
- Sponsor's protocol ID
- LC2024ZD026
- Acronym
- CAIS-MT
- Status last verified
- Jul 2025
- First submitted
- 6 Apr 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Intracranial Artery Calcification on Adverse Outcomes of Large Vessel Occlusive, Acute Ischemic Stroke Patients After Mechanical Thrombectomy: A Prospective Cohort, Observational Study
- ClinicalTrials.gov ID
- NCT06418698
- Acronym / sponsor ID
- CAIS-MT / LC2024ZD026
- Conditions
- Stroke, Acute, Ischemic Stroke, Vascular Diseases, Central Nervous System Diseases, Nervous System Diseases, Stroke
- Keywords
- Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Endovascular treatment, Agatston score, Prospective cohort study, Intracranial atherosclerotic disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 May 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.
CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or medium vessel occlusion.
Detailed description
This study have to objective to evaluate the predictive value of IAC Agatston score in patients with acute ischemic stroke due to large or medium vessel occlusion on worse angiographic and functional outcomes after EVT. The result of this study will provide a upfront basis for risk stratification of adverse outcomes of EVT by using quantitative IAC, so as to get a reference for an individualized and precise plan of EVT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke due to large or medium vessel occlusion | – | –Patients with acute ischemic stroke due to large or medium vessel occlusion meeting inclusion criteria, must accept mechanical thrombectomy and have CT images which can get the IAC Agatston score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of acute ischemic stroke due to large or medium vessel occlusion, who are enrolled at Zhujiang Hospital and meet the indication for EVT.
Key inclusion criteria (6 listed)
- Male or non-pregnant women with acute stroke symptoms aged over 18 years.
- Occlusion of the intracranial internal carotid artery, the middle cerebral artery, the anterior cerebral artery, the posterior cerebral artery, basilar artery and intracranial vertebral artery confirmed by CT, MR angiography, or digital subtraction angiography.
- No absolute contraindication to iodinated contrast media.
- Planned treatment with EVT by clinical care team.
- Informed consent obtained from patients or their legal representatives.
Key exclusion criteria (6 listed)
- Acute ischemic stroke occurs over 24 hours of time last known well.
- Neurologic deficits caused by diagnoses other than ischemic stroke, such as intracerebral hemorrhage, subarachnoid hemorrhage, or intracranial tumors.
- With other underlying factors leading to IAC, such as hyperthyroidism, end-stage renal disease, long-term oral intake of vitamin K antagonist(Warfarin), chronic vitamin D deficiency or overdose, persistent hypomagnesemia, persistent hypercalcemia, persistent hyperphosphatemia and high oral calcium intake.
- Lack of non-contract CT images on admission and significant artifacts in CT images preventing IAC measurement.
- Severe renal insufficiency (estimated glomerular filtration rate < 30ml/min or serum creatinine > 220μmol/L (2.5mg/dl)).
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
Proportion of patients with a adverse functional outcome at 3 months
Time frame: 90(±7) days
Modified Rankin Scale(mRS) score > 2
18 secondary outcomes
Proportion of patients without disability at 3 months
Time frame: 90(±7) days
Proportion of patients with functional independence at 3 months
Time frame: 90(±7) days
Proportion of patients ambulatory or bodily needs-capable or better at 3 months
Time frame: 90(±7) days
Change of the NIHSS score at 24 hours from baseline
Time frame: 24 hours
Change of the NIHSS score at 6 days or discharge if earlier from baseline
Time frame: 6(±1) days
Health-related quality of life at 3 months
Time frame: 90(±7) days
Proportion of substantial reperfusion at final angiogram
Time frame: 0 day
Proportion of substantial reperfusion at final angiogram without any rescue methods
Time frame: 0 day
Proportion of substantial reperfusion at first angiogram
Time frame: 0 day
Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours
Time frame: Within 48 hours
Proportion of patients with any ICH within 48 hours
Time frame: Within 48 hours
Mortality at 3 months
Time frame: 90(±7) days
Incidence of serious adverse events
Time frame: Within 3 years
Procedure-related complications
Time frame: Up to 24 hours
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year
Time frame: 365(±30) days
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years
Time frame: 1095(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year
Time frame: 365(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years
Time frame: 1095(±30) days
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 28 Jul 2025.
- 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.
Duan Chuanzhi, MD principal investigator
Zhujiang 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 Stroke, Acute and Ischemic Stroke, run by Zhujiang 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 6 inclusion and 6 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 28 Jul 2025. 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?
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 Feng Xin, MD (+8613681134001, 13681134001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a adverse functional outcome at 3 months (time frame: 90(±7) days). 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 28 Jul 2025.