Impact of CalmiGo's stress device on heart health after a heart attack
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
This study is testing whether using the CalmiGo stress management device can help improve heart health in people who have recently had a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04521699 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the CalmiGo stress management device in improving vascular health and reducing cardiovascular disease risk in patients who have recently experienced a myocardial infarction. A total of 100 participants will be enrolled and randomized into two groups: one receiving the CalmiGo device along with standard care, and the other receiving only standard care. Participants will undergo various assessments, including EndoPAT testing and blood tests, before and after a 12-week intervention period. The primary outcome will focus on changes in peripheral endothelial function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently suffered a myocardial infarction and are undergoing cardiac rehabilitation.
Not a fit: Patients with cognitive impairments or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to enhancing recovery and reducing cardiovascular risks in patients post-heart attack.
How similar studies have performed: While the use of stress management devices is gaining interest, this specific approach has not been extensively tested in similar populations, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Valentina Nardi, M.D. — Mayo Clinic
- Study coordinator: Anna Pick
- Email: pick.anna@mayo.edu
- Phone: 507-255-0630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.