A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Trial ID or NCT#
NCT03936660
Status
RECRUITING
Purpose
COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.
Official Title
COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Chiara Orlando
650-721-8437
View on ClinicalTrials.gov
