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Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Health and Cardiovascular Disease Risk , and Markers of Mental Stress in Patients Following a Myocardial Infarction Participating in Clinically Indicated Cardiac Rehabilitation
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 18 years of age or older * Ability to use the CamliGo device for 12-weeks * Willingness to complete study questionnaires, blood tests,\& EndoPat testing at the beginning and end of study * Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation * Patients who have had a coronary or structural intervention performed in the cardiac catheterization laboratory within the last month, including: coronary stenting; coronary balloon angioplasty; transcatheter aortic valve replacement; mitral valve interventions; patent foramen ovale closures; alcohol septal ablation; paravalvular leak closure. * Patients being seen in the Chest Pain Clinic for Atypical chest pain Exclusion Criteria: * Cognitively impaired patients * Patient with Bipolar disorder, psychosis or delusional disorder * History of substance abuse or dependence * History of suicidality * Unstable cardiovascular or pulmonary disease * History of seizures * Latex allergy
About the study
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.
What is being tested
- CalmioGO Stress management device (device)
Sponsor: Mayo Clinic · Participants: 100 · Started: Jan 13, 2022
Contact the study team
- Anna Pick · Phone: 507-255-0630
- Diana Albers · Phone: 507-255-6884
Official record on ClinicalTrials.gov — NCT04521699
Locations in the U.S.
| Minnesota | Mayo Clinic in Rochester, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.