Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk. (CalmiGo)
Primary Purpose
Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CalmioGO Stress management device
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
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 the beginning and end of study
- Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation
Exclusion Criteria:
- Pregnant Patient
- 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CalmioGo + Standard of care
Standard of Care
Arm Description
Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation
Stand of care alone with 12 weeks of Cardiac rehabilitation
Outcomes
Primary Outcome Measures
Peripheral endothelial function
Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment
Secondary Outcome Measures
Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.
Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.
Full Information
NCT ID
NCT04521699
First Posted
August 19, 2020
Last Updated
February 16, 2023
Sponsor
Mayo Clinic
Collaborators
CalmiGO
1. Study Identification
Unique Protocol Identification Number
NCT04521699
Brief Title
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Acronym
CalmiGo
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
CalmiGO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CalmioGo + Standard of care
Arm Type
Experimental
Arm Description
Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Stand of care alone with 12 weeks of Cardiac rehabilitation
Intervention Type
Device
Intervention Name(s)
CalmioGO Stress management device
Intervention Description
CalmiGo device is a device of similar size to an inhaler that uses guided breathing, and grounding techniques to regulate breathing to bring users a sense of calm and relaxation.
Primary Outcome Measure Information:
Title
Peripheral endothelial function
Description
Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.
Description
Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 the beginning and end of study
Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation
Exclusion Criteria:
Pregnant Patient
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Priebe
Phone
507-422-6932
Email
Priebe.Amanda@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Albers
Phone
507-255-6884
Email
Albers.Diana2@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Lerman
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Priebe
Phone
507-422-6932
Email
Priebe.Amanda@mayo.edu
First Name & Middle Initial & Last Name & Degree
Diana Albers
Phone
507-255-6884
Email
Albers.Diana2@mayo.edu
First Name & Middle Initial & Last Name & Degree
Amir Lerman, MD
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
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