CalmiGo Device for Cardiovascular Disease (CalmiGo Trial)

N/A

Recruiting

Led By Amir Lerman

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Must not have

History of seizures

Unstable cardiovascular or pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new therapy can improve peripheral endothelial function better than the current standard of care.

Who is the study for?

This trial is for adults who've had a recent heart attack and are starting cardiac rehab. They must be able to use the CalmiGo stress management device for 12 weeks and complete various health tests. It's not open to pregnant individuals, those with certain mental health conditions, unstable heart or lung disease, seizures, cognitive impairments, substance abuse history, or past suicidality.

What is being tested?

The study is testing if using the CalmiGo stress management device along with standard care over 12 weeks improves blood vessel function compared to just standard care. Participants will be randomly assigned to either receive the device or not.

What are the potential side effects?

Since this trial involves a non-invasive stress management device rather than medication, side effects may be minimal but could include discomfort from wearing the device or potential frustration if difficulties in operating it are encountered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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I do not have unstable heart or lung conditions.

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I have cognitive impairments.

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I have a history of suicidal thoughts or actions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peripheral endothelial function

Secondary study objectives

Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.