A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Media… (NCT06903078) | Clinical Trial Compass
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A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
United States375 participantsStarted 2025-02-13
Plain-language summary
The purpose of this observational research study is to study if patients with herpes zoster, also known as Shingles, have a higher risk of vascular dysfunction (problems with blood vessels, including stroke) and vascular dementia (problems with mental decline as a result of decreased blood flow to the brain) compared to patients without herpes zoster.
Patients are evaluated based on the group they are assigned too:
1. Herpes Zoster (HZ) Group: individuals presenting with untreated herpes zoster. These participants will have 6 visits:
* Day 1 = 1st day presenting to clinic with acute zoster
* 7 days post zoster
* 1 month after Day 1
* 3 months after Day 1
* 6 months after Day 1
* 12 months after Day 1
2. Control Group: individuals without herpes zoster o Day 1 (only 1 visit will be completed)
This study does not have a study medication/device. Standard of care for all patients will be followed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be a male or female ≥ 18 years of age.
✓. Present to clinic for routine dermatologic evaluation with or without rash.
✓. Are willing and able to complete study visits and procedures, and able to effectively communicate with the investigator and other study personnel.
✓. Have adequate venous access and are willing to undergo venipuncture for blood draws.
✓. Able to provide written informed consent prior to any study procedures. Additional inclusion criteria for Herpes zoster (HZ) participants,
✓. Present with acute, vesicle-stage HZ that has not been treated with antiviral therapies
✓. Are willing and have reliable transportation to complete additional follow-up visits at 7 days, 1 month, 3 months, 6 months, and 12 months after initial visit for acute HZ.
Exclusion criteria
✕. Female individuals who are pregnant or breast-feeding.
✕
What they're measuring
1
Analyze exosome content for known vascular damaging proteins/miRNAs from matched control and HZ individuals over a 12-month period.
Timeframe: From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner.