RECRUITINGINTERVENTIONAL
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States