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

Early Phase 1

• Conditions: Heart Injuries
• Interventions: Drug: 0.9%NaCl solution; Drug: Dexmedetomidine

• Registration Number: NCT03095469
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-02-26
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-03-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-09
• Study Start: 2017-08-20
• Primary Completion: 2017-11-30
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Read 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	0.9%NaCl solution	0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI.
study group	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

the 1st affiliated hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China