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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | 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. |
|
| control group | Placebo Comparator | 0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maijuan Dong, MD | Contact | 0086-15991666714 | dmjxiaomai@163.com | |
| Qiang Wang, PHD | Contact | 0086-18049286968 | dr.wangqiang@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Wang, PHD | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the 1st affiliated hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D006335 | Heart Injuries |
| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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coronary artery disease patients with anxiety who receive selective PCI
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all of the participants, operators, investigators and outcomes assessors don't know the grouping situation before the study finished.
|
| 0.9%NaCl solution | Drug | when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h 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 |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |