Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CalmioGO Stress management device.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Peripheral endothelial function [Time frame: 16 weeks]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04521699 · 20-005047