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

NCT03284281 | Withdrawn DMC FDA Device

• 1 other identifier: 8350
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

STEMI - ST Elevation Myocardial Infarction; Inflammation

Outcome Measures

Primary Outcomes (3)

• Change in CRP levels

  mg/dL

  Change from admission to 1 month post discharge

• Change in TNF-alpha and TGF-beta levels

  ng/L

  Change from admission to 1 month post discharge

• Change in interleukin levels (IL-1,IL-6,IL-10)

  ng/L

  Change from admission to 1 month post discharge

Secondary Outcomes (1)

• Major adverse cardiac events

  Admission to 1 year post discharge

Study Arms (2)

Interventional arm

EXPERIMENTAL

Active TVNS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 8 hours daily (4 hours twice daily) for 1-week post discharge.

Device: Tragus stimulator

Control arm

PLACEBO COMPARATOR

No stimulation will be performed.

Device: Sham Tragus stimulator

Interventions

Tragus stimulator DEVICE

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

Interventional arm

Sham Tragus stimulator DEVICE

No stimulation will be performed

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (18 years or older) with ST Segment elevation myocardial infarction (STEMI) undergoing primary PCI.

You may not qualify if:

• Patients transferred in from outside facilities after having received fibrinolytic therapy
• patients in cardiogenic shock
• patients with pacemakers and defibrillators
• patients undergoing urgent coronary bypass surgery
• cardiac arrest patients
• mechanical complications (ventricular septal defects, acute papillary muscle rupture, free wall rupture)
• patients on mechanical ventilation
• chronic inflammatory disease (systemic lupus erythematosus, rheumatoid arthritis, and Crohn's disease), or receiving therapy with steroids, cyclosporine, or methotrexate
• unilateral or bilateral vagotomy
• pregnant patients
• prisoners
• end stage renal disease on dialysis
• history of recurrent vasovagal syncope, Sick sinus syndrome, 2nd or 3rd degree AV block.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Inflammation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: September 15, 2017
• Study Start: March 19, 2018
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03

Locations

US (1)