Clinical Trial: Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial

Brief Summary: Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has sedative and analgesic effects. Dex currently has been widely used in perioperative management of various surgical.This study intends to verify the effect of heart protection of Dex in perioperative.

Detailed Summary: Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. Dexmedetomidine and 0.9 % NaCl solution will be transfused when the operation began, ending 24 hours after the surgery. Troponin I level(but are not limited to these data) at pre-operation and 3h, 6h,12h, 24h, 48h after PCI will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 12 months.
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current Primary Outcome: the incidence of myocardial infarction type 4a (MI4a) [ Time Frame: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI ]

serum troponin(TnI) values at 48h after PCI is an important indicator for diagnosis of acute myocardial injury myocardial damage when troponin I lever rise.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • post-procedural cardiac function [ Time Frame: once 3 months for 6 months after PCI ]
    Echocardiographic results can reflect cardiac function.Echocardiography index include left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter (LVEDD), left ventricular end-diastolic volume (LVEDV) and stroke volume (SV),doppler mitral flow E/A ratio(E/A).
  • major adverse cardiac events(MACEs) [ Time Frame: once 3 months for 12 months after PCI ]
    MACEs' incidence reflects the incidence of MI4a
  • systemic inflammatory markers [ Time Frame: before and 1 week after PCI ]
    systemic inflammatory markers can reflect the situation of cardiac injures,like tumor necrosis factor alpha(TNF-α),interleukin-6(IL-6),interleukin-8(IL-8),high-sensitivity C-reactive protein(hs-CRP).


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: February 26, 2017
Date Started: April 20, 2017
Date Completion: December 31, 2017
Last Updated: April 21, 2017
Last Verified: February 2017