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

Primary Purpose

Heart Injuries

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9%NaCl solution
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • the 1st affiliated hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
major adverse cardiac events(MACEs)
MACEs' incidence reflects the incidence of MI4a
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).

Full Information

First Posted
February 26, 2017
Last Updated
June 7, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03095469
Brief Title
Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention
Acronym
EODOPWCHD
Official Title
Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Anticipated)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
coronary artery disease patients with anxiety who receive selective PCI
Masking
ParticipantCare ProviderInvestigator
Masking Description
all of the participants, operators, investigators and outcomes assessors don't know the grouping situation before the study finished.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9%NaCl solution
Other Intervention Name(s)
Other Name: normal saline
Intervention Description
when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.
Primary Outcome Measure Information:
Title
the incidence of myocardial infarction type 4a (MI4a)
Description
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.
Time Frame
detect serum TnI level before and 3h、6h、12h、24h、48h after PCI
Secondary Outcome Measure Information:
Title
post-procedural cardiac function
Description
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).
Time Frame
once 3 months for 6 months after PCI
Title
major adverse cardiac events(MACEs)
Description
MACEs' incidence reflects the incidence of MI4a
Time Frame
once 3 months for 12 months after PCI
Title
systemic inflammatory markers
Description
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).
Time Frame
before and 1 week after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maijuan Dong, MD
Phone
0086-15991666714
Email
dmjxiaomai@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Wang, PHD
Phone
0086-18049286968
Email
dr.wangqiang@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, PHD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
the 1st affiliated hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Maijuan, MD
Phone
0086-15991666714
Email
dmjxiaomai@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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