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:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT07117695
Eligibility Criteria:
Inclusion Criteria:
1. Adults ≥ 18 years of age
2. Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)
3. Type 2 Diabetes
4. Uncontrolled sBP AND LDL-C within the preceding 3 months:
* SBP \> 150mmHg on at least 1 occasion in last 3 months, AND
* LDL \> 130mg/dL in last 3 months
* NOTE: If there are not enough patients with the above inclusion criteria available for enrollment, then we will expand the criteria to include patients with uncontrolled sBP and LDL-C within the last 6 months.
Exclusion Criteria:
1. Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey)
2. History of advanced dementia
3. Referred to hospice/on hospice
4. Lives outside of Durham County, Orange County, Wake County, Person County or Granville County
5. End Stage Renal Disease (those on dialysis or with EGFR \<20)
6. History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure
7. Pregnant/Planning to become pregnant during study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07117695
Study Brief:
Protocol Section:
NCT07117695