NCT04521699 Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
| NCT ID | NCT04521699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-01-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-01-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Valentina Nardi, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04521699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04521699 currently recruiting?
Yes, NCT04521699 is actively recruiting participants. Contact the research team at pick.anna@mayo.edu for enrollment information.
Where is the NCT04521699 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04521699 clinical trial?
NCT04521699 is sponsored by Mayo Clinic. The principal investigator is Valentina Nardi, M.D. at Mayo Clinic. The trial plans to enroll 100 participants.