The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy

NCT06418698 | Recruiting DMC

• 1 other identifier: LC2024ZD026
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a adverse functional outcome at 3 months

  Modified Rankin Scale(mRS) score \> 2

  90(±7) days

Secondary Outcomes (18)

• 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

• Change of the NIHSS score at 24 hours from baseline

  24 hours

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

  6(±1) days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 528400, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Duan Chuanzhi, MD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Xin, MD

CONTACT

+8613681134001; 13681134001@163.com

Wen Zhuohua, MD

CONTACT

+8615622311746; 810107327@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: May 17, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)