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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04521699
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
CalmiGO
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Device: CalmioGO Stress management device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2022
Estimated Primary Completion Date : January 13, 2023
Estimated Study Completion Date : January 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: CalmioGo + Standard of care
Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation
Device: CalmioGO Stress management device
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.

No Intervention: Standard of Care
Stand of care alone with 12 weeks of Cardiac rehabilitation



Primary Outcome Measures :
  1. Peripheral endothelial function [ Time Frame: 16 weeks ]
    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 :
  1. Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress. [ Time Frame: 16 weeks ]
    Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521699


Contacts
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Contact: Jacob W Bjerke 507-422-0467 Bjerke.Jacob@mayo.edu
Contact: Allison H Smith 507-422-6932 Smith.Allison3@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jacob Bjerke    507-422-0467    Bjerke.Jacob@mayo.edu   
Principal Investigator: Amir Lerman, MD         
Sponsors and Collaborators
Mayo Clinic
CalmiGO
Investigators
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Principal Investigator: Amir Lerman Mayo Clinic
Additional Information:
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Responsible Party: Amir Lerman, Dr. Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04521699    
Other Study ID Numbers: 20-005047
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases