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NCT04521699Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
19 Aug 2020
Start date
13 Jan 2022
Primary completion date
31 Dec 2026
Lead sponsor
Mayo Clinic
NCT number
NCT04521699

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 13 Jan 2022 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Cognitively impaired patients

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.