Use Dexmedetomidine To Protect Myocardial Injury Evaluation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
The goal of this clinical trial is to learn if preoperative intranasal dexmedetomidine works to reduce perioperative myocardial injury and myocardial infarction in patients undergoing elective percutaneous coronary intervention (PCI). It will also learn about the safety of intranasal dexmedetomidine. The main questions it aims to answer are:
Does preoperative intranasal dexmedetomidine lower the incidence of perioperative myocardial injury and myocardial infarction after PCI? Does intranasal dexmedetomidine cause safety concerns in patients undergoing PCI? Researchers will compare intranasal dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if intranasal dexmedetomidine works to protect the heart during PCI.
Participants will:
Receive either intranasal dexmedetomidine (100 μg) or a placebo (normal saline) 15 minutes before the PCI procedure Undergo blood tests to measure cardiac troponin levels before and after the procedure Be followed for up to 30 days after the procedure to record any heart-related events or side effects
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years ≤ age ≤ 85 years;
Patients scheduled to undergo elective coronary angiography or percutaneous coronary intervention (PCI);
Classified as American Society of Anesthesiologists (ASA) physical status I-III (ranging from patients with mild systemic disease to those with more severe systemic disease that limits normal physical activity but who remain able to perform light daily tasks);
Informed consent obtained.
Disqualifiers
Allergy or contraindication to dexmedetomidine, such as severe bradycardia (resting heart rate <50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without a pacemaker;
Severe cardiac dysfunction (left ventricular ejection fraction <35% or New York Heart Association functional class III-IV), cardiogenic shock, or hemodynamically unstable patients;
Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) or hypotension (systolic blood pressure <90 mmHg);
Sleep apnea-hypopnea syndrome or Body Mass Index >30 kg/m²;
Trial design
Design model
Parallel
Treatments tested in this trial
Intranasal Dexmedetomidine
DrugThe subjects received intranasal dexmedetomidine (100 μg, sprayed equally into both nostrils, two sprays per nostril) 15 minutes before surgery in the preoperative preparation area.
Normal saline
DrugThe subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine GroupExperimental treatment 1 intervention
Group B: Normal saline GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite incidence of perioperative myocardial injury and myocardial infarction
Perioperative Myocardial Injury and Perioperative Myocardial Infarction: As defined by the Fourth Universal Definition of Myocardial Infarction
Time frame
from the end of surgery to 48 hours after surgerySecondary outcomes
1
Incidence of perioperative myocardial injury
Perioperative Myocardial Injury
Time frame
from the end of surgery to 48 hours after surgery2
Incidence of perioperative myocardial infarction
Perioperative Myocardial infarction
Time frame
from the end of surgery to 48 hours after surgery3
Incidence of severe perioperative myocardial injury
severe perioperative myocardial injury：For patients with normal baseline cTn levels, a cTn elevation exceeding 5 times the 99th percentile upper reference limit (URL) within 48 hours after PCI .For patients with elevated baseline cTn levels, the post-procedural cTn value must increase by \>20% from baseline, and the absolute post-procedural cTn value must exceed 5 times the 99th percentile upper reference limit (URL).
Time frame
from the end of surgery to 48 hours after surgery4
Incidence of major adverse cardiac and cerebrovascular events (MACCE) within 4 and 12 weeks after surgery
Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
Time frame
4 and 12 weeks after surgeryOther outcomes
1
Incidence of MACCE at 1 year after surgery
Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
Time frame
1 year after surgery2
Quality of life scores at 1 year after surgery
Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D) EuroQol Five-Dimensional Questionnaire (EQ-5D): The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status.
Time frame
1 year after surgery3
Quality of life scores at 1 year after surgery
Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Kansas City Cardiomyopathy Questionnaire (KCCQ): The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life.
Time frame
1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov
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