Imaging neuroinflammation in asymptomatic carotid artery disease
Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
This study is testing a special imaging technique to see if it can help us understand inflammation in the brains of people with asymptomatic carotid artery disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05238961 on ClinicalTrials.gov |
What this trial studies
This imaging substudy aims to investigate neuroinflammation in individuals with asymptomatic carotid artery disease (aCAD) using a specific PET tracer, [18F]DPA-714. Participants will be categorized into two cohorts based on the severity of their carotid artery stenosis: critical and non-critical. The study will utilize advanced imaging techniques to assess the binding of the tracer to activated microglia/macrophages, providing insights into the neuroinflammatory processes associated with aCAD. This research is part of a larger study led by Dr. Ron Lazar at the University of Alabama at Birmingham.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with either critical or non-critical asymptomatic carotid artery stenosis who meet specific inclusion criteria.
Not a fit: Patients with symptomatic carotid artery disease or those not meeting the inclusion criteria for either cohort may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of neuroinflammation in asymptomatic carotid artery disease, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: While this approach is novel in the context of asymptomatic carotid artery disease, similar imaging studies have shown promise in understanding neuroinflammation in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort 1 - Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria: 1. Critical Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with \>70% stenosis or peak systolic velocity on DUS ≥ 230 cm/s plus CTA or MRA confirmation. 2. Participation in University of Alabama at Birmingham (UAB) IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar). 3. Male or female age \>18 years 4. English speaking with at least 8th grade education 5. High affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971 6. Planned revascularization for aCAD in \>14 days from time of consent Cohort 2 - Non-Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria: 1. Participation in UAB IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar). 2. \<40% carotid stenosis 3. No planned revascularization 4. Male or female age 18 or older 5. English speaking with at least 8th grade education 6. High affinity binder for TSPO ligands based on genotyping SNP rs6971 Exclusion Criteria: 1. Contraindication to MRI 2. Pregnancy or lactation 3. Previous revascularization for treatment of aCAD 4. Prior stroke 5. Severe anemia (blood hemoglobin ≤ 8 mg/dL) 6. Previously obtained MRI scan with evidence of clinically significant abnormality 7. History of traumatic head injury defined by loss of consciousness \>30 minutes or seizure at the time of the injury 8. Major depression 9. Known history of dementia 10. Serious medical comorbidity that, based on the judgement of the principal investigator, may interfere with study participation 11. Low or mixed-affinity binding for TSPO ligands based on genotyping for SNP rs6971.
Where this trial is running
Birmingham, Alabama
- UAB — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan McConathy, MD,PhD — University of Alabama at Birmingham
- Study coordinator: Evan Hudson
- Email: evanhudson@uabmc.edu
- Phone: 205-934-6499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.