Low-Level Transcutaneous Vagus Stimulation in ST Segment Elevation Myocardial Infarction: TREAT MI Study
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: STEMI - ST Elevation Myocardial Infarction, Inflammation
In brief
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.
Key facts
- Study ID
- NCT03284281
- Run by
- University of Oklahoma
- People needed
- 0
- Starts
- 2018-03-19
- Expected to finish
- 2018-03-19
- Last updated by the study team
- 2018-04-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- OUHSC — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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