A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03936660

Run by

Duke University

People needed

1049

Starts

2019-07-25

Expected to finish

2022-12-30

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Diagnosis of Type 2 diabetes mellitus (T2DM)
• History of at least one of the following conditions:
• Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
• Stroke and/or carotid artery stenosis (≥50%)
• 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

You may not qualify if…

• 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

Where it is running

• Grandview Health/Alabama Cardiovascular Group — Birmingham, Alabama, United States
• USA Cardiology — Mobile, Alabama, United States
• Alaska Heart and Vascular Institute — Anchorage, Alaska, United States
• Dignity Health/DHMG Specialty Medicine — Phoenix, Arizona, United States
• Stanford University — Stanford, California, United States
• Blue Coast Cardiology — Vista, California, United States
• Aurora Denver Cardiology — Denver, Colorado, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Orlando Heart and Vascular Institute — Altamonte Springs, Florida, United States
• Riverside Medical Center/Synergy Healthcare — Bradenton, Florida, United States
• Lennar Foundation/Univ. of Miami — Coral Gables, Florida, United States
• Citrus Cardiology — Inverness, Florida, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• Advanced Research for Health Improvement, LLC — Naples, Florida, United States
• Cardiovascular Inst. of Northwest Florida — Panama City, Florida, United States
• Bayfront Cardiovascular Associates — St. Petersburg, Florida, United States
• Interventional Cardiac Consultants — Trinity, Florida, United States
• Emory/Grady Memorial Hospital — Atlanta, Georgia, United States
• Advocate Heart Institute — Chicago, Illinois, United States
• Advanced Heart Care Group/Medicoricium LLC — Fairview Heights, Illinois, United States
• Specialty Physicians of Illinois — Olympia Fields, Illinois, United States
• UnityPoint Health Cardiovascular Services — Peoria, Illinois, United States
• Prairie Cardiovascular Consultants — Springfield, Illinois, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Heart Clinic of Louisiana — Marrero, Louisiana, United States

Full record on ClinicalTrials.gov

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