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

NCT03095469 | Unknown Early Phase 1

• 1 other identifier: XJTU1AF-CRF-2016T-09
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• post-procedural cardiac function

  once 3 months for 6 months after PCI

• major adverse cardiac events(MACEs)

  once 3 months for 12 months after PCI

• systemic inflammatory markers

  before and 1 week after PCI

Study Arms (2)

study group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Drug: 0.9%NaCl solution

Interventions

Dexmedetomidine DRUG

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.

Also known as: Dexmedetomidine Injection

study group

0.9%NaCl solution DRUG

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

Also known as: Other Name: normal saline

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the 1st affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Heart Injuries

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Qiang Wang, PHD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Maijuan Dong, MD

CONTACT

0086-15991666714; dmjxiaomai@163.com

Qiang Wang, PHD

CONTACT

0086-18049286968; dr.wangqiang@139.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: all of the participants, operators, investigators and outcomes assessors don't know the grouping situation before the study finished.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: coronary artery disease patients with anxiety who receive selective PCI

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 29, 2017
• Study Start: August 20, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 31, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Locations

CN (1)