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

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Heart Injuries

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: 0.9%NaCl solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients were coincided to CHD combined with depression and anxiety according to diagnostic standard of World Health Organization(WHO)who need receive selective PCI in the First Affiliated Hospital of Xi'an Jiaotong University; people aged over 18; patients who will undergo PCI with Hamilton Anxiety scale of 14 points or more. Exclusion Criteria: severe comorbidity history; coronary stenosis less than 70%; severe cardiac dysfunction; central nervous system disease; troponin I levels have rised before entering the hospital; pregnant woman； history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: coronary artery disease patients with anxiety who receive selective PCI
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24 h after PCI. | Drug: Dexmedetomidine<br>* when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24h after PCI.<br>* Other names: Dexmedetomidine Injection;|
| Placebo Comparator: control group<br>0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI. | Drug: 0.9%NaCl solution<br>* when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.<br>* Other names: Other Name: normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of myocardial infarction type 4a (MI4a) | 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. | detect serum TnI level before and 3h、6h、12h、24h、48h after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-procedural cardiac function | 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). | once 3 months for 6 months after PCI | 
| major adverse cardiac events(MACEs) | MACEs' incidence reflects the incidence of MI4a | once 3 months for 12 months after PCI | 
| systemic inflammatory markers | 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). | before and 1 week after PCI |