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

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: Myocardial Infarction
• Intervention / Treatment: Device: CalmioGO Stress management device

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

• Study Contact: Name: Amanda Priebe; Phone Number: 507-422-6932; Email: Priebe.Amanda@mayo.edu
• Study Contact Backup: Name: Diana Albers; Phone Number: 507-255-6884; Email: Albers.Diana2@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Amanda Priebe; Phone Number: 507-422-6932; Email: Priebe.Amanda@mayo.edu
      • Contact: Diana Albers; Phone Number: 507-255-6884; Email: Albers.Diana2@mayo.edu
      • Principal Investigator: Amir Lerman, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	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

• Sponsor: Mayo Clinic
• Collaborators: CalmiGO
• Investigators: Principal Investigator: Amir Lerman, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

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): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Cardiovascular Diseases
• Other Study ID Numbers: 20-005047

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