Heart Injuries
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
all of the participants, operators, investigators and outcomes assessors don't know the grouping situation before the study finished.
Intervention model description
coronary artery disease patients with anxiety who receive selective PCI
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of myocardial infarction type 4a (MI4a) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-procedural cardiac function | 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) | once 3 months for 12 months after PCI | MACEs' incidence reflects the incidence of MI4a |
| systemic inflammatory markers | 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). |
Countries
China
Contacts
Primary ContactMaijuan Dong, MD
Backup ContactQiang Wang, PHD
Outcome results
None listed