Recruiting

CalmiGo

Sponsor:

Mayo Clinic

Code:

NCT04521699

Conditions

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CalmioGO Stress management device

Study Details

Brief 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.

Conditions

Myocardial Infarction

Study ID

NCT04521699

Start date

Jan 13, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CalmioGo + Standard of care

Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation

no intervention: Standard of Care

Stand of care alone with 12 weeks of Cardiac rehabilitation

Interventions

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.

Primary outcome measure

  • Peripheral endothelial function [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Anna Pick

507-255-0630pick.anna@mayo.edu

Diana Albers

507-255-6884Albers.Diana2@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amanda Priebe

507-422-6932Priebe.Amanda@mayo.edu

Diana Albers

507-255-6884Albers.Diana2@mayo.edu

Principal Investigator:

Valentina Nardi, MD

More Information

Sponsor

Mayo Clinic

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-05.