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Low-Level Transcutaneous Vagus Stimulation in ST Segment Elevation Myocardial Infarction: TREAT MI Study

NCT03284281 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-04-03

No results posted yet for this study

Summary

This study will determine the impact of Transcutaneous Vagus Stimulation(TVNS) and autonomic modulation of inflammation in patients admitted with " acute heart attack."

After admission for "acute heart attack" or "myocardial infarction" patients will be randomized to either TVNS or placebo and their blood samples will be collected at different time points during admission and post discharge.

Blood samples will be analyzed for various markers of inflammation.

Conditions

Interventions

DEVICE

Tragus stimulator

Tragus nerve stimulation for at least 8 hours per day for 1 week post discharge.

DEVICE

Sham Tragus stimulator

No stimulation will be performed

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2018-03-19
Completion
2018-03-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284281 on ClinicalTrials.gov