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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03095469

Collaborator

(none)

200

Enrollment

Location

Arms

4.4

Anticipated Duration (Months)

45.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Injuries	Drug: Dexmedetomidine Drug: 0.9%NaCl solution	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

coronary artery disease patients with anxiety who receive selective PCIcoronary artery disease patients with anxiety who receive selective PCI

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

all of the participants, operators, investigators and outcomes assessors don't know the grouping situation before the study finished.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2017

Anticipated Primary Completion Date :

Nov 30, 2017

Anticipated Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group 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.	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. Other Names: Dexmedetomidine Injection
Placebo Comparator: control group 0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI.	Drug: 0.9%NaCl solution when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI. Other Names: Other Name: normal saline

Arm

Intervention/Treatment

Experimental: study group

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.

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.

Other Names:

Dexmedetomidine Injection

Placebo Comparator: control group

0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI.

Drug: 0.9%NaCl solution

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

Other Names:

Other Name: normal saline

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the 1st affiliated hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

Study Chair: Qiang Wang, PHD, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT03095469

Other Study ID Numbers:

XJTU1AF-CRF-2016T-09

First Posted:

Mar 29, 2017

Last Update Posted:

Jun 9, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Diseases

Coronary Disease

Coronary Artery Disease

Myocardial Ischemia

Heart Injuries

Dexmedetomidine

Study Results

No Results Posted as of Jun 9, 2017