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

Heart Injuries Clinical Trial

— EODOPWCHD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03095469
• Other study ID #: XJTU1AF-CRF-2016T-09
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: February 26, 2017
• Last updated: June 7, 2017
• Start date: August 20, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Maijuan Dong, MD
• Phone: 0086-15991666714
• Email: dmjxiaomai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Heart Injuries
• Myocardial Ischemia

Intervention

Drug:
• 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 24h after PCI.
• 0.9%NaCl solution
when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.

Locations

Country	Name	City	State
China	the 1st affiliated hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	major adverse cardiac events(MACEs)	MACEs' incidence reflects the incidence of MI4a	once 3 months for 12 months after PCI
Secondary	systemic inflammatory markers	systemic inflammatory markers can reflect the situation of cardiac injures,like tumor necrosis factor alpha(TNF-a),interleukin-6(IL-6),interleukin-8(IL-8),high-sensitivity C-reactive protein(hs-CRP).	before and 1 week after PCI