Status:
RECRUITING
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
CalmiGO
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 testin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04521699
Start Date
January 13 2022
End Date
December 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905