Clinical trial NCT06418698: The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Ischemic Stroke
Vascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Calcification
Keywords: Acute ischemic stroke
Large vessel occlusion
Mechanical thrombectomy
Endovascular treatment
Agatston score
Prospective cohort study
Intracranial atherosclerotic disease
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with a adverse functional outcome at 3 months
timeFrame: 90(±7) days
Secondary outcomes:
measure: Proportion of patients without disability at 3 months
timeFrame: 90(±7) days
measure: Proportion of patients with functional independence at 3 months
timeFrame: 90(±7) days
measure: Proportion of patients ambulatory or bodily needs-capable or better at 3 months
timeFrame: 90(±7) days
measure: Change of the NIHSS score at 24 hours from baseline
timeFrame: 24 hours
measure: Change of the NIHSS score at 6 days or discharge if earlier from baseline
timeFrame: 6(±1) days
measure: Health-related quality of life at 3 months
timeFrame: 90(±7) days
measure: Proportion of substantial reperfusion at final angiogram
timeFrame: 0 day
measure: Proportion of substantial reperfusion at final angiogram without any rescue methods
timeFrame: 0 day
measure: Proportion of substantial reperfusion at first angiogram
timeFrame: 0 day
measure: Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours
timeFrame: Within 48 hours
measure: Proportion of patients with any ICH within 48 hours
timeFrame: Within 48 hours
measure: Mortality at 3 months
timeFrame: 90(±7) days
measure: Incidence of serious adverse events
timeFrame: Within 3 years
measure: Procedure-related complications
timeFrame: Up to 24 hours
measure: Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year
timeFrame: 365(±30) days
measure: Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years
timeFrame: 1095(±30) days
measure: Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year
timeFrame: 365(±30) days
measure: Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years
timeFrame: 1095(±30) days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Duan Chuanzhi, MD
role: PRINCIPAL_INVESTIGATOR
References: