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

June 7, 2017 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • the 1st affiliated hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of myocardial infarction type 4a (MI4a)
Time Frame: 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.
detect serum TnI level before and 3h、6h、12h、24h、48h after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-procedural cardiac function
Time Frame: 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).
once 3 months for 6 months after PCI
major adverse cardiac events(MACEs)
Time Frame: once 3 months for 12 months after PCI
MACEs' incidence reflects the incidence of MI4a
once 3 months for 12 months after PCI
systemic inflammatory markers
Time Frame: 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).
before and 1 week after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 20, 2017

Primary Completion (Anticipated)

November 30, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

February 26, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2016T-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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