Clinical trial NCT06447714: A Study on the Correlation Between Cotinine Levels and Aneurysm Wall Enhancement on HRMRI.
Official title: A Prospective Cohort Study on the Correlation Between Patient Cotinine Levels and Intracranial Unruptured Aneurysm Wall Enhancement Based on High-resolution Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cotinine Levels
Arterial Aneurysm Wall Enhancement on HRMRI
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed intracranial unruptured aneurysm patient through DSA/MRA/CTA examination

Brief summary: This study aims to collect clinical, laboratory, and imaging data from patients with unruptured intracranial aneurysms, and collect blood or urine samples for cotinine testing. The enrolled patients underwent high-resolution magnetic resonance angiography to detect whether the intracranial aneurysm wall was enhanced and classify the degree of enhancement. The purpose is to study the correlation between arterial aneurysm wall enhancement and cotinine levels

Detailed description: This study aims to explore the relationship between cotinine levels and the risk of intracranial aneurysm rupture by collecting imaging features and patient cotinine levels of unruptured intracranial aneurysms on high-resolution magnetic resonance imaging, combined with the prognosis of patients with aneurysms. Previous studies have shown that the risk of intracranial aneurysm rupture in patients is related to the enhancement of the aneurysm wall on high-resolution magnetic resonance imaging. Therefore, this study included patients who met the inclusion criteria for high-resolution magnetic resonance imaging and cotinine testing, and followed up on the imaging characteristics, prognostic scores, and aneurysm occlusion rate of arterial aneurysms in patients.

Eligibility 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

Primary outcomes:
measure: High resolution MRI aneurysm features
timeFrame: 1 year
measure: postoperative 12 month mRS score
timeFrame: 1 year
measure: postoperative 12 month aneurysm occlusion rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: