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

Overview

About this study

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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Aged 18 years of age or older.
  • Ability to use the CGo device for 12-weeks.
  • Willingness to complete study questionnaires, blood testing and EndoPAT testing at the beginning and end of the study.
  • Patients who have had a recent acute myocardial infarction (MI) who will be undergoing clinically indicated cardiac rehabilitation (CR).

Exclusion Criteria: 

  • Under 18 years of age.
  • Cognitively impaired patients.
  • Patients with uncontrolled Bipolar disorder, psychosis or delusional disorders.
  • History of substance abuse or dependence.
  • History of suicidality.
  • Unstable cardiovascular or pulmonary diseases.
  • History of seizures.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amir Lerman, M.D.

Open for enrollment

Contact information:

Diana Albers

(507) 255-6884

Albers.Diana2@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20507922

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