A Study on the Correlation Between Cotinine Levels and Aneurysm Wall Enhancement on HRMRI.

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 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

Study Overview

• Status: Recruiting
• Conditions: Cotinine Levels; Arterial Aneurysm Wall Enhancement on HRMRI
• Intervention / Treatment: Behavioral: smoke

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.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Xin Feng, MD; Phone Number: +8613681134001; Email: 13681134001@163.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: Yes

• Sampling Method: Probability Sample

Study Population

Confirmed intracranial unruptured aneurysm patient through DSA/MRA/CTA examination

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No aneurysm wall enhancement; The aneurysm wall did not show enhanced signal on high-resolution magnetic resonance imaging.
Aneurysm wall enhancement; The aneurysm wall shows enhanced signal on high-resolution magnetic resonance imaging.	Behavioral: smoke; cotinine detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High resolution MRI aneurysm features	Enhancement grade was defined as follows: grade 0 for none enhancement, grade 1 for focal enhancement, involved the neck, the intermediate portion, the dome, or a bleb;grade 2 for thin annular enhancement (maximum thickness≤1 mm) , grade 3 for thick annular enhancement(maximum thickness>1 mm) .	1 year
postoperative 12 month mRS score	MRS score definition: The MRS score, also known as the Modified Rankin Scale, is a scale used to evaluate the neurological recovery status of stroke patients. It is divided into seven levels, Level 0: completely asymptomatic. Level 1: Despite symptoms, without obvious disabilities, able to complete all frequently engaged work and activities. Level 2: Mild disability, unable to complete all work and activities, but able to handle personal affairs without the need for assistance from others. Level 3: Moderate disability, requiring assistance from others to walking without assistance. Level 4: Severe disability, unable to walk without the help of others, unable to take care of one's own needs. Level 5: Severe disability, bedridden, urinary and fecal incontinence, requiring continuous care, and requiring multiple 24-hour care from others. Level 6: Death. The higher the mRS score, the worse the patient's prognosis.	1 year
postoperative 12 month aneurysm occlusion rate	Raymond classification, grade I: complete embolism; Grade II: residual aneurysm neck; Grade III: Residual aneurysm cavity. The higher the Raymond grade, the lower the successful embolization rate of the patient's aneurysm. OKM classification is A1/A2/A3; B1/B2/B3; C1/C2/C3; D/Unsuccessful (note: A, B, C, D represent the volume of contrast agent filled aneurysm, A represents>95%, B represents 5-95%, C represents<5%, D represents no filling). 1, 2, and 3 represent the degree of contrast agent retention in the aneurysm, 1 represents only retention in the arterial phase, 2 represents retention continuing into the capillary phase, and 3 represents still retention in the venous phase.	1 year

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm
• Other Study ID Numbers: LC2024ZD028

Drug and device information, study documents

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