Evaluating the impact of artery calcification on stroke treatment outcomes
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
This study is trying to see if the amount of calcium in the arteries affects how well stroke patients do after a specific treatment for blocked blood vessels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 434 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06418698 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between intracranial artery calcification (IAC) and the outcomes of endovascular treatment (EVT) in patients suffering from acute ischemic stroke due to large or medium vessel occlusion. By utilizing the Agatston score to quantify IAC, the study seeks to predict adverse angiographic and functional outcomes following EVT. The findings will help in risk stratification and may guide personalized treatment plans for affected patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with acute ischemic stroke symptoms and confirmed large or medium vessel occlusion.
Not a fit: Patients with neurologic deficits from conditions other than ischemic stroke or those with acute ischemic stroke occurring more than 24 hours prior will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment outcomes for stroke patients, leading to more tailored and effective interventions.
How similar studies have performed: While the correlation between artery calcification and stroke outcomes is being explored, this specific approach using the Agatston score in the context of EVT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Duan Chuanzhi, MD — Zhujiang Hospital
- Study coordinator: Feng Xin, MD
- Email: 13681134001@163.com
- Phone: +8613681134001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.