Examining the link between cotinine levels and aneurysm wall enhancement using MRI
A Prospective Cohort Study on the Correlation Between Patient Cotinine Levels and Intracranial Unruptured Aneurysm Wall Enhancement Based on High-resolution Magnetic Resonance Imaging
This study looks at whether levels of cotinine in the body are connected to changes in the walls of unruptured brain aneurysms as seen on MRI, to help understand the risk of these aneurysms getting worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06447714 on ClinicalTrials.gov |
What this trial studies
This observational study collects clinical, laboratory, and imaging data from patients with unruptured intracranial aneurysms to investigate the correlation between cotinine levels and aneurysm wall enhancement observed through high-resolution magnetic resonance imaging (HRMRI). Participants will undergo HRMRI to assess the degree of enhancement of their aneurysm walls, while also providing blood or urine samples for cotinine testing. The study aims to understand how these factors relate to the risk of aneurysm rupture and the overall prognosis of patients with intracranial aneurysms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with diagnosed unruptured intracranial aneurysms suitable for endovascular intervention.
Not a fit: Patients with arteriovenous malformations, Moyamoya disease, or those unable to undergo high-resolution MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the risk factors for aneurysm rupture, potentially leading to improved patient management and treatment strategies.
How similar studies have performed: Previous studies have indicated a relationship between aneurysm wall enhancement and rupture risk, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years old, male or infertile female; * Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment * The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books; * Patients willing to cooperate with high-resolution magnetic resonance imaging. * Patients willing to follow up and evaluate according to clinical research protocol requirements Exclusion Criteria: * AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms; * Patients with contraindications for high-resolution magnetic resonance imaging; * Participants in clinical trials of other drugs or medical devices; * Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery; * Patients with poor compliance and inability to cooperate with follow-up; * Possible or clear history of severe allergy to contrast agents; * Patients with a life expectancy of less than 2 years; * Women who are breastfeeding and preparing for pregnancy during the study period
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xin Feng, 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.