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NCT Number: NCT06418698

The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Calcification Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of patients with a adverse functional outcome at 3 months

    Time frame: 90(±7) days

    Modified Rankin Scale(mRS) score > 2

Secondary outcomes

  1. Proportion of patients without disability at 3 months

    Time frame: 90(±7) days

    mRS score 0-1

  2. Proportion of patients with functional independence at 3 months

    Time frame: 90(±7) days

    mRS score 0-2

  3. Proportion of patients ambulatory or bodily needs-capable or better at 3 months

    Time frame: 90(±7) days

    mRS score 0-3

  4. Change of the NIHSS score at 24 hours from baseline

    Time frame: 24 hours

    Change of the NIHSS score at 24 hours from baseline

  5. Change of the NIHSS score at 6 days or discharge if earlier from baseline

    Time frame: 6(±1) days

    Change of the NIHSS score at 6 days or discharge if earlier from baseline

  6. Health-related quality of life at 3 months

    Time frame: 90(±7) days

    Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)

  7. Proportion of substantial reperfusion at final angiogram

    Time frame: 0 day

    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)

  8. Proportion of substantial reperfusion at final angiogram without any rescue methods

    Time frame: 0 day

    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)

  9. Proportion of substantial reperfusion at first angiogram

    Time frame: 0 day

    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)

  10. Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours

    Time frame: 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.

  11. Proportion of patients with any ICH within 48 hours

    Time frame: Within 48 hours

    ICH will be evaluated according to the Heidelberg Bleeding Classification.

  12. Mortality at 3 months

    Time frame: 90(±7) days

    Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.

  13. Incidence of serious adverse events

    Time frame: Within 3 years

    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.

  14. Procedure-related complications

    Time frame: Up to 24 hours

    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.

  15. Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year

    Time frame: 365(±30) days

    New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.

  16. Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years

    Time frame: 1095(±30) days

    New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.

  17. Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year

    Time frame: 365(±30) days

    New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.

  18. Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years

    Time frame: 1095(±30) days

    New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Xin, MD

CONTACT

[email protected]

+8613681134001

Wen Zhuohua, MD

CONTACT

[email protected]

+8615622311746

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study 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

Acronym: CAIS-MT

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
May 17, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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