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

Early Phase 1UnknownNCT03095469

First Affiliated Hospital Xi'an Jiaotong University200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

200

Conditions

Heart Injuries

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI

Secondary Outcomes

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).

Time frame: once 3 months for 6 months after PCI

major adverse cardiac events(MACEs)

MACEs' incidence reflects the incidence of MI4a

Time frame: 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).

Time frame: before and 1 week after PCI