Cotinine LevelsNCT06447714
A Study on the Correlation Between Cotinine Levels and Aneurysm Wall Enhancement on HRMRI.
An observational study of Cotinine Levels and Arterial Aneurysm Wall Enhancement on HRMRI, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cotinine Levels, Arterial Aneurysm Wall Enhancement on HRMRI
- What is being tested?
- smoke
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Confirmed intracranial unruptured aneurysm patient through DSA/MRA/CTA examination
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 528400
Feng Xin, MD, +8613681134001, 13681134001@163.com
Wen Zhuohua, MD, +8615622311746, 810107327@qq.com
About this study
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
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
Read the 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.
- Being tested
- smoke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smokeBehavioural
cotinine detection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: smoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Sep 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cotinine LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447714
- Sponsor's protocol ID
- LC2024ZD028
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06447714
- Acronym / sponsor ID
- LC2024ZD028
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No aneurysm wall enhancement | – | –The aneurysm wall did not show enhanced signal on high-resolution magnetic resonance imaging. |
| Aneurysm wall enhancement | – | Behavioral: smokeThe aneurysm wall shows enhanced signal on high-resolution magnetic resonance imaging. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed intracranial unruptured aneurysm patient through DSA/MRA/CTA examination
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smokecotinine detection | Behavioural | Aneurysm wall enhancement |
Primary outcome
High resolution MRI aneurysm features
Time frame: 1 year
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) .
postoperative 12 month mRS score
Time frame: 1 year
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.
postoperative 12 month aneurysm occlusion rate
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cotinine Levels and Arterial Aneurysm Wall Enhancement on HRMRI, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Feng, MD (+8613681134001, 13681134001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High resolution MRI aneurysm features (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.