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| Name | Class |
|---|---|
| CalmiGO | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CalmioGo + Standard of care | Experimental | Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation |
|
| Standard of Care | No Intervention | Stand of care alone with 12 weeks of Cardiac rehabilitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CalmioGO Stress management device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Pick | Contact | 507-255-0630 | pick.anna@mayo.edu | |
| Diana Albers | Contact | 507-255-6884 | Albers.Diana2@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Nardi, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |