RecruitingNot ApplicableNCT04521699

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

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

Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Jan 13, 2022

Study Type

INTERVENTIONAL

Conditions

Myocardial Infarction

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 completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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

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Interventions

DEVICECalmioGO Stress management 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.