Clinical trial NCT04521699: Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: CalmiGO
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peripheral endothelial function
timeFrame: 16 weeks
Secondary outcomes:
measure: Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman
role: PRINCIPAL_INVESTIGATOR
References: