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

April 29, 2026 updated by: Valentina Nardi, Mayo Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valentina Nardi, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CalmioGo + Standard of care
Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation
Device: CalmioGO 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.
No Intervention: Standard of Care
Stand of care alone with 12 weeks of Cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral endothelial function
Time Frame: 16 weeks
Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.
Time Frame: 16 weeks
Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

CalmiGO

Investigators

  • Principal Investigator: Valentina Nardi, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-005047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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