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Recruiting NCT06418698

The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy

— Observational Stroke, Acute Ischemic Stroke Vascular Diseases Central Nervous System Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Acute, Ischemic Stroke, Vascular Diseases, Central Nervous System Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Primary outcome measures

  • Proportion of patients with a adverse functional outcome at 3 months [Time frame: 90(±7) days]
Secondary outcome measures (12)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhujiang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT06418698 · LC2024ZD026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗