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

Launched by MAYO CLINIC · Aug 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a stress management device called CalmiGo on heart health, specifically looking at how it may improve blood vessel function in patients who have recently experienced a heart attack (myocardial infarction). The main goal is to see if using the CalmiGo device, along with standard care, makes a difference compared to standard care alone after 12 weeks.

To be eligible for this study, participants should be at least 18 years old and able to use the CalmiGo device for the duration of the trial. They should also be willing to complete some questionnaires and undergo blood tests. Participants must have had a recent heart attack and be enrolled in a cardiac rehabilitation program. It's important to note that individuals with certain health issues, like severe mental health disorders or unstable heart conditions, cannot participate. If chosen, participants will use the CalmiGo device and take part in assessments at the start and end of the study to see how their vascular health may have changed.

Gender

ALL

Eligibility criteria

• 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