A Study on the Correlation Between Cotinine Levels and Aneurysm Wall Enhancement on HRMRI.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhujiang Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Confirmed intracranial unruptured aneurysm patient through DSA/MRA/CTA examination
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
smoke
Behavioralcotinine detection
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: No aneurysm wall enhancement0 interventions
Group B: Aneurysm wall enhancement1 intervention
Trial outcomes
Primary outcomes
1
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) .
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov