NCT06418698RecruitingNot Applicable
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
Zhujiang Hospital1 site in 1 country434 target enrollmentStarted: March 28, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 434
- Locations
- 1
- Primary Endpoint
- Proportion of patients with a adverse functional outcome at 3 months
Study Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Proportion of patients with a adverse functional outcome at 3 months
Time Frame: 90(±7) days
Modified Rankin Scale(mRS) score \> 2
Secondary Outcomes
- Proportion of patients with any ICH within 48 hours(Within 48 hours)
- Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years(1095(±30) days)
- Change of the NIHSS score at 6 days or discharge if earlier from baseline(6(±1) days)
- Proportion of substantial reperfusion at final angiogram(0 day)
- Proportion of substantial reperfusion at final angiogram without any rescue methods(0 day)
- Change of the NIHSS score at 24 hours from baseline(24 hours)
- Health-related quality of life at 3 months(90(±7) days)
- Mortality at 3 months(90(±7) days)
- Proportion of patients without disability at 3 months(90(±7) days)
- Proportion of patients with functional independence at 3 months(90(±7) days)
- Proportion of patients ambulatory or bodily needs-capable or better at 3 months(90(±7) days)
- Proportion of substantial reperfusion at first angiogram(0 day)
- Procedure-related complications(Up to 24 hours)
- Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year(365(±30) days)
- Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours(Within 48 hours)
- Incidence of serious adverse events(Within 3 years)
- Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year(365(±30) days)
- Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years(1095(±30) days)
Investigators
Study Sites (1)
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