Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.

Mayo Clinic

Status: Enrolling

Conditions: Myocardial Infarction

Treatments: Device: CalmioGO Stress management device

Study type: Interventional

Funder types: Other

Identifiers

NCT04521699

20-005047

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CalmioGo + Standard of care

Experimental group

Description:

Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation

Treatment:

Device: CalmioGO Stress management device

Standard of Care

No Intervention group

Description:

Stand of care alone with 12 weeks of Cardiac rehabilitation