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

Last updated: December 13, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Myocardial Ischemia

Angina

Treatment

CalmioGO Stress management device

Clinical Study ID

NCT04521699
20-005047
  • Ages > 18
  • All Genders

Study 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

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 thebeginning and end of study

  • Patients who have had a recent MI who will be undergoing clinically indicatedCardiac Rehabilitation

  • Patients who have had a coronary or structural intervention performed in the cardiaccatheterization laboratory within the last month, including: coronary stenting;coronary balloon angioplasty; transcatheter aortic valve replacement; mitral valveinterventions; patent foramen ovale closures; alcohol septal ablation; paravalvularleak closure.

  • Patients being seen in the Chest Pain Clinic for Atypical chest pain

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: CalmioGO Stress management device
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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