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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03936660
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Diagnosis of Type 2 diabetes mellitus (T2DM)
* History of at least one of the following conditions:
1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
2. Stroke and/or carotid artery stenosis (≥50%)
3. Peripheral Arterial disease (defined as claudication with ABI\<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
* Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:
* Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
* GFR\<30 mL/min/1.73m2
* Already on all guideline-recommended therapies for T2DM and CVD
* Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03936660
Study Brief:
Protocol Section:
NCT03936660