RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-13
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04521699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Ability to use the CamliGo device for 12-weeks
  3. * Willingness to complete study questionnaires, blood tests,\& EndoPat testing at the beginning and end of study
  4. * Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation
  5. * 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.
  6. * Patients being seen in the Chest Pain Clinic for Atypical chest pain
  1. * Cognitively impaired patients
  2. * Patient with Bipolar disorder, psychosis or delusional disorder
  3. * History of substance abuse or dependence
  4. * History of suicidality
  5. * Unstable cardiovascular or pulmonary disease
  6. * History of seizures
  7. * Latex allergy

Contacts and Locations

Study Contact

Amanda Priebe
CONTACT
507-422-6932
Priebe.Amanda@mayo.edu
Diana Albers
CONTACT
507-255-6884
Albers.Diana2@mayo.edu

Principal Investigator

Amir Lerman
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Amir Lerman, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-13
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-01-13
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Myocardial Infarction