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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Device: CalmioGO Stress management device

• Registration Number: NCT04521699
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Study Start: 2022-01-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CalmioGo + Standard of care	CalmioGO Stress management device	Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation

Primary Outcome Measures

Name	Time	Method
Peripheral endothelial function	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States