Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04521699

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

Led by Mayo Clinic · Updated on 2026-05-05

100

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

C

CalmiGO

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Ability to use the CalmiGo device for 12 weeks
  • Willingness to complete study questionnaires, blood tests, and EndoPAT testing at the beginning and end of the study
  • Recent myocardial infarction and undergoing clinically indicated cardiac rehabilitation
  • Had a coronary or structural intervention within the last month, including coronary stenting, balloon angioplasty, valve replacement or interventions, septal ablation, or leak closure
  • Being seen in the Chest Pain Clinic for atypical chest pain
Not Eligible

You will not qualify if you...

  • Cognitive impairment
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

A

Anna Pick

CONTACT

D

Diana Albers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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