Clinical trial NCT03095469: Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention
Official title: Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Heart Injuries
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: coronary artery disease patients with anxiety who receive selective PCI
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: the incidence of myocardial infarction type 4a (MI4a)
timeFrame: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI
Secondary outcomes:
measure: post-procedural cardiac function
timeFrame: once 3 months for 6 months after PCI
measure: major adverse cardiac events(MACEs)
timeFrame: once 3 months for 12 months after PCI
measure: systemic inflammatory markers
timeFrame: before and 1 week after PCI
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the 1st affiliated hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Qiang Wang, PHD
role: STUDY_CHAIR
References: