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Ethical review opinion of Quanzhou First Hospital


Quan Yilun [2019] No. 155


The name of the research project


Effect of remote ischemia combined with non-invasive transcutaneous auricular vagus nerve stimulation on reperfusion injury in acute myocardial infarction and its long-term efficacy


Proposed study time


October 01, 2019 - July 31, 2022


Project Leader


Wang Ling


Job title


Deputy Chief Physician


Contact number

13808523225


Email

13808523225@163.com


Briefly describe the research content related to ethics:


All patients were randomly divided into three groups according to the ratio of 1:1:1: transcutaneousvagalnerve stimulation (TVNS), transcutaneous auricular vagal nerve stimulation combined with remote limb ischemia management group (RIPC+TVNS), Control group, all three groups routinely received coronary angiography and direct PCI and standardized treatment of coronary heart disease drugs according to the requirements of the guidelines. The TVNS group applied e-stim


(S20, Jinjiang, Chengdu, China) was used for low-frequency square wave pulse stimulation (20 Hz) at the tragus of the right ear


pulse width 1 ms) and gradually increase the current intensity until a slowing of the sinus heart rate occurs. will slow down the sinus rate as needed


The lowest current is defined as the stimulation threshold. The TVNS parameter is set to 50% below the threshold, and the duty cycle is 5 seconds, off


Closed for 5 sec, procedure begins after the patient arrives at the catheterization lab, and the PCI balloon dilation (reperfusion) is performed


Lasts 2 hours after that; In the combination therapy group, after admission and during transfer to the catheterization laboratory for coronary angiography, a sphygmomanometer cuff was used simultaneously and intermittently to compress and inflate to 200 mmHg in the left upper arm for 5 minutes to induce limb ischemia and post-deflation, and this process was divided into 4 cycles, with 5 minutes between each cycle, and TVNS was routinely performed. In the control group, there was no additional treatment other than conventional PCI.


Approval Opinions:


The study does not violate ethical principles and agrees to conduct the study with informed consent.


Ethics Committee of Quanzhou Sixth Hospital