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

Description

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.

Conditions

Myocardial Infarction

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Myocardial Infarction
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Amir Lerman, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-01