NCT07079345Recruiting
PET/MR Multimodal Quantitative Analysis of CBF and CMRGlc in Cerebral Ischemia
PET/MR Multimodal Quantitative Imaging of Cerebral Ischemia With CBF and CMRGlc Assessment in Cephalo-Carotid Atherosclerosis
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
Research Purpose: This project focuses on clinical research issues in the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis. Through multimodal imaging technology, it aims to optimize non-invasive quantitative algorithm models for cerebral blood flow and cerebral metabolism, explore new imaging markers, and investigate quantitative indicators of cerebral blood flow and metabolism for the diagnosis, treatment, and evaluation of patients with cephalic and carotid atherosclerosis undergoing drug therapy or surgical treatment. Research Design: 1. Study Type: Observational study 2. Study Subjects: In accordance with the \*Chinese Clinical Management Guidelines for Cerebrovascular Diseases (2nd Edition)\*, patients with cephalic and carotid atherosclerotic stenosis admitted to the department of neurosurgery will be enrolled. Data collection time points are at enrollment, 6-month follow-up, and 12-month follow-up. 3. Sample Size: 200 patients with cephalic and carotid atherosclerotic stenosis. 4. Observation Indicators: Distribution patterns of cerebral blood flow and metabolic reduction areas in patients; correlation analysis between blood flow, metabolic values and clinical scores. 5. Statistical Analysis Methods: Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) version 21.0. All statistical results will be expressed as mean ± standard deviation. First, the Shapiro-Wilk test will be used to assess normal distribution. Under the premise of normal distribution, paired t-test will be used to compare blood flow and metabolic values between the lesion area and the contralateral area of patients, as well as to compare changes in blood flow and metabolism of patients at different time points. Pearson correlation analysis will be used to analyze the relationship between blood flow/metabolic parameters and clinical neurological function scores. The Mann-Whitney U test will be used to analyze variables with non-normal distribution. A P value \< 0.05 will be considered statistically significant.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 14 Jul 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- Stroke
- NCT number
- NCT07079345
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Jul 2025 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus, etc.)
- Presence of other systemic diseases that can cause cognitive impairment, such as hepatic insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid and vitamin B12 deficiency, specific infections (such as syphilis, HIV), alcohol and drug abuse, etc
- Presence of other known diseases that may cause cognitive impairmentPresence of other known diseases that may cause cognitive impairment
- Individuals with severe visual or hearing impairment, claustrophobia, or other conditions that prevent cooperation with MRI examination
- Individuals suffering from diseases that make it impossible to cooperate with cognitive examinations
Other
- Poor image quality caused by head movement or other reasons during scanning
- Refusal to sign the informed consent form at baseline
Who the study is looking for
- Angiography diagnosed unilateral anterior circulation head carotid artery stenosis, the diameter of the tube was reduced by \>70%, and the contralateral anterior circulation and bilateral posterior circulation did not exceed the stenosis of \>50% of the diameter reduction;
- Must have had a transient ischemic attack or ischemic stroke within the area of the diseased vessel within the past 12 months, with the most recent onset being more than 3 weeks;
- MRI showed no new infarct lesions in the skull;
- There is no infarct lesion in the previous pontine area;
- Research participants and informants can complete relevant examinations and follow-ups;
- Informed consent signed by the study participant or his/her authorized representative;
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospitail, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.