About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cognitively impaired patients
Patient with Bipolar disorder, psychosis or delusional disorder
History of substance abuse or dependence
History of suicidality
Trial design
Parallel
Treatments tested in this trial
CalmioGO Stress management device
DeviceCalmiGo device is a device of similar size to an inhaler that uses guided breathing, and grounding techniques to regulate breathing to bring users a sense of calm and relaxation.
Treatment groups
Trial outcomes
Primary outcomes
Peripheral endothelial function
Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment
Secondary outcomes
Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.
Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
CalmiGO
Collaborator