Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT05295758
Eligibility Criteria:
Inclusion Criteria:
* In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Self-identified Black/African Americans
2. Detroit-area residents (defined as those who attend attended a Detroit-area community event)
3. \> 18 years of age
4. Screening systolic BP 130-139 and diastolic BP \< 90 mm Hg
5. Not currently taking medications for HTN (Untreated)
6. 10-year cardiovascular risk \< 10% per ASCVD calculator (as such nearly all patients will be \<50-55 years of age)
7. Baseline home systolic BP 120-159 mm Hg and diastolic BP \< 100 mm Hg
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
1. History of clinical cardiovascular disease (CVD)
2. History of kidney disease or eGFR \<60 mL/min from screening labs
3. Self-reported pregnancy (or planning to be pregnant in the next year)
4. History of diabetes or HbA1c \> 6.5% from SOC screening labs
5. Non-HDL-C \> 220 mg/dL from SOC labs (potential genetic hyperlipidemia)
6. Arm circumference \> 18'' (home BP arm cuff will be inaccurate)
7. Baseline home BP average \> 160mm Hg systolic and/or \>100 mm Hg diastolic
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT05295758
Study Brief:
Protocol Section:
NCT05295758