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Behavioural Intervention

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

CalmiGo Trial 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.Check my eligibility

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.See study design

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.

CalmiGo Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

CalmiGo Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peripheral endothelial function

Secondary outcome measures

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

CalmiGo Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CalmioGo + Standard of careExperimental Treatment1 Intervention

Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation

Group II: Standard of CareActive Control1 Intervention

Stand of care alone with 12 weeks of Cardiac rehabilitation

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,911 Total Patients Enrolled

CalmiGOUNKNOWN

Amir LermanPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

51 Total Patients Enrolled

Media Library

CalmioGO Stress management device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04521699 — N/A

Heart Attack Research Study Groups: CalmioGo + Standard of care, Standard of Care

Heart Attack Clinical Trial 2023: CalmioGO Stress management device Highlights & Side Effects. Trial Name: NCT04521699 — N/A

CalmioGO Stress management device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04521699 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial recruiting?

"Affirmative. According to clinicaltrials.gov, this medical trial was first posted on January 13th 2022 and is actively recruiting participants. An estimated 100 patients are required for the study at one site of enrolment."

Answered by AI

Are there still opportunities for individuals to become involved in this research?

"According to clinicaltrials.gov, this medical research is actively searching for new participants as of February 1st 2022. It initially opened its doors on January 13th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Amir Lerman 2022. "Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521699.

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