The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy (CAIS-MT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemic Stroke; Stroke, Acute; Intracranial Arterial Calcification

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 Type: Observational
• Enrollment (Estimated): 434

Contacts and Locations

• Study Contact: Name: Feng Xin, MD; Phone Number: +8613681134001; Email: 13681134001@163.com
• Study Contact Backup: Name: Wen Zhuohua, MD; Phone Number: +8615622311746; Email: 810107327@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 528400
      • Recruiting
      • Zhujiang Hospital, Southern Medical University
      • Contact: Feng Xin, MD; Phone Number: +8613681134001; Email: 13681134001@163.com
      • Contact: Wen Zhuohua, MD; Phone Number: +8615622311746; Email: 810107327@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a adverse functional outcome at 3 months	Modified Rankin Scale(mRS) score > 2	90(±7) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients without disability at 3 months	mRS score 0-1	90(±7) days
Proportion of patients with functional independence at 3 months	mRS score 0-2	90(±7) days
Proportion of patients ambulatory or bodily needs-capable or better at 3 months	mRS score 0-3	90(±7) days
Change of the NIHSS score at 24 hours from baseline	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	Change of the NIHSS score at 6 days or discharge if earlier from baseline	6(±1) days
Health-related quality of life at 3 months	Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)	90(±7) days
Proportion of substantial reperfusion at final angiogram	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)	0 day
Proportion of substantial reperfusion at final angiogram without any rescue methods	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)	0 day
Proportion of substantial reperfusion at first angiogram	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)	0 day
Proportion of patients with Symptomatic intracranial hemorrhage(sICH) 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.	Within 48 hours
Proportion of patients with any ICH within 48 hours	ICH will be evaluated according to the Heidelberg Bleeding Classification.	Within 48 hours
Mortality at 3 months	Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.	90(±7) days
Incidence of serious adverse events	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.	Within 3 years
Procedure-related complications	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.	Up to 24 hours
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year	New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.	365(±30) days
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years	New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.	1095(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year	New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.	365(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years	New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.	1095(±30) days

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Duan Chuanzhi, MD, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; Prospective cohort study; Endovascular treatment; Large vessel occlusion; Mechanical thrombectomy; Intracranial atherosclerotic disease; Agatston score
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Stroke; Vascular Diseases; Ischemic Stroke; Ischemia; Nervous System Diseases; Brain Diseases; Cerebrovascular Disorders; Calcinosis; Central Nervous System Diseases
• Other Study ID Numbers: LC2024ZD026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No