Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascu… (NCT04521699) | Clinical Trial Compass
RecruitingNot Applicable
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
United States100 participantsStarted 2022-01-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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