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

NCT06447714 | Recruiting

• 1 other identifier: LC2024ZD028
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Conditions

Cotinine Levels; Arterial Aneurysm Wall Enhancement on HRMRI

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Interventions

smoke BEHAVIORAL

cotinine detection

Aneurysm wall enhancement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 528400, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient plasma sample

MeSH Terms

Interventions

Smoke

Intervention Hierarchy (Ancestors)

Particulate Matter; Complex Mixtures

Central Study Contacts

Xin Feng, MD

CONTACT

+8613681134001; 13681134001@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: September 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

CN (1)