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

NCT04521699 | Recruiting FDA Device

• 1 other identifier: 20-005047
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peripheral endothelial function

  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 Outcomes (1)

• Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.

  16 weeks

Study Arms (2)

CalmioGo + Standard of care

EXPERIMENTAL

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

Device: CalmioGO Stress management device

Standard of Care

NO INTERVENTION

Stand of care alone with 12 weeks of Cardiac rehabilitation

Interventions

CalmioGO Stress management device 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.

CalmioGo + Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CalmiGO: collaborator
• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Valentina Nardi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Pick

CONTACT

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

Diana Albers

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Valentina Nardi

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 20, 2020
• Study Start: January 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)