Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Amanda Priebe
CONTACT
Diana Albers
CONTACT
Valentina Nardi, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04521699
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Amanda Priebe
CONTACT
Diana Albers
CONTACT
Valentina Nardi, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CalmiGo 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.
Time frame: 16 weeks
Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment
Time frame: 16 weeks
Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.
Contact information is provided by the study sponsor or research team.
Anna Pick
CONTACT
Diana Albers
CONTACT
Mayo Clinic
Other
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
Acronym: CalmiGo
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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