Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Start Date
1/13/2022
Completion Date
12/1/2026
Summary
The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.
Detailed Description
100 patients who have recently had an acute Myocardial Infarction ( heart attack) and are under going clinically indicated cardiac rehabilitation will undergo baseline testing including EndoPAT testing, mental stress testing, blood tests for cardiovascular disease biomarkers , physical assessments \& survey questionnaires. Patients then will be randomized to either CalmioGO stress management device + standard of care treatment or just standard of care treatment. Those randomized to CalmiGO stress management device treatment will be instructed to use the hand device much like an inhaler once a day for 12 weeks. After 12 weeks of rehabilitation both groups will return for reassessment of baseline tests.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CalmioGO Stress management device
Conditions
Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States