Status:
WITHDRAWN
Low-Level Transcutaneous Vagus Stimulation in ST Segment Elevation Myocardial Infarction: TREAT MI Study
Lead Sponsor:
University of Oklahoma
Conditions:
STEMI - ST Elevation Myocardial Infarction
Inflammation
Eligibility:
All Genders
18-80 years
Phase:
NA
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 hea...
Detailed Description
SPECIFIC AIMS: 1. Study the effects of TVNS on inflammation in patients with STEMI. 2. Determine the clinical impact of TVNS on 30, 3,6 and 12-month clinical outcomes in patients with STEMI. B: BACK...
Eligibility Criteria
Inclusion
- Patients (18 years or older) with ST Segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Exclusion
- 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.
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03284281
Start Date
March 19 2018
End Date
March 19 2018
Last Update
April 3 2018
Active Locations (1)
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1
OUHSC
Oklahoma City, Oklahoma, United States, 73104