Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.

{ "CalmiGo Device for Vascular Health After Heart Attack", "This study is looking at whether using the CalmiGo stress management device can improve blood vessel health in people who have recently had a heart attack (myocardial infarction). The CalmiGo device is a small, inhaler-sized tool that uses guided breathing to help you relax. Researchers want to see if using CalmiGo for 12 weeks, along with your usual care, makes a difference compared to just receiving usual care. They will measure changes in your peripheral endothelial function (how well your blood vessels work) to see if the device is helpful. You might be able to join if you are 18 or older, have recently had a heart attack, and are starting cardiac rehabilitation. The current recruitment status is unclear.", "design": "This study plans to enroll 100 participants. Participants will be randomly assigned to either use the CalmiGo device plus standard care, or standard care alone.", "commitments": "You would use the CalmiGo device once a day for 12 weeks if assigned to that group. You will also have blood tests, mental stress testing, physical assessments, and surveys at the beginning and end of the study.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be reassessed after 12 weeks of treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT04521699

Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~100 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:CalmioGO Stress management device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peripheral endothelial function
Measured over 16 weeks
Myocardial Infarction
1 sites across 1 states
Minnesota1
  • Valentina Nardi, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Peripheral endothelial function16 weeks

    Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment