Use Dexmedetomidine To Protect Myocardial Injury Evaluation

Phase 4Not Yet RecruitingNCT07549282

Second Affiliated Hospital, School of Medicine, Zhejiang University1,800 enrolled

Overview

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

Coronary heart disease (CHD) remains a major global health burden. Percutaneous coronary intervention (PCI) has become a cornerstone treatment for CHD, effectively reducing mortality. Despite its success, perioperative myocardial injury (PMI) is a frequent complication, occurring in 5-30% of patients, depending on the definition and sensitivity of cardiac biomarkers. PMI ranges from a mild, asymptomatic increase in high-sensitivity cardiac troponin (hs-cTn) to overt myocardial infarction. Even minor elevations in troponin are independently associated with increased 30-day and long-term major adverse cardiovascular events (MACE), as well as higher rates of stent thrombosis and restenosis. The pathophysiology of PMI is multifactorial, including distal embolization, side-branch occlusion, coronary dissection, and, importantly, an imbalance between myocardial oxygen supply and demand during the procedure. Sedation is commonly used during PCI to relieve anxiety, pain, and stress; however, the choice of sedative and its impact on myocardial outcomes remain controversial. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, provides sedation with minimal respiratory depression and has shown potential cardioprotective effects in preclinical and clinical studies, possibly through reducing sympathetic tone, decreasing myocardial oxygen consumption, and attenuating inflammatory and oxidative stress responses. Intranasal administration offers a non-invasive, convenient route with rapid absorption, making it an attractive option for premedication. Nevertheless, robust evidence from large-scale, multicenter randomized controlled trials is lacking. This trail is designed to evaluate whether preoperative intranasal dexmedetomidine reduces the incidence of perioperative myocardial injury and myocardial infarction in patients undergoing elective PCI compared with placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Use of alpha-2 adrenergic receptor agonists (e.g., clonidine) or antagonists, or tricyclic antidepressants, which may affect the action of the study drug, within 1 month before the procedure; * Language, visual, or hearing impairment that may affect cognitive assessment; * Hepatic or renal insufficiency (Alanine Aminotransferase/Aspartate Aminotransferase/Creatinine \>3 times the upper limit of normal); * Anatomical abnormalities of the nasal cavity affecting intranasal drug administration; * Pregnant or breastfeeding women.

Outcomes

Primary Outcomes

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 surgery

Secondary Outcomes

Incidence of perioperative myocardial injury

Perioperative Myocardial Injury

Time frame: from the end of surgery to 48 hours after surgery

Incidence of perioperative myocardial infarction

Perioperative Myocardial infarction

Time frame: from the end of surgery to 48 hours after surgery

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 surgery

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 surgery

Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery

Unplanned hospital readmission

Time frame: 4 and 12 weeks after surgery

Variability of mean arterial pressure and systolic blood pressure

Hemodynamic variable

Time frame: From operating room admission to 24 hours postoperatively

Change in perioperative anxiety scores

Anxiety was assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater anxiety. Anxiety was also assessed using the Perioperative Anxiety Scale-7 (PAS-7) , which ranges from 0 to 28, with higher scores indicating greater anxiety.

Time frame: Before intervention; after intervention but before surgery; 1 day after surgery

Change in perioperative cardiac enzyme levels

Myocardial enzyme level

Time frame: Baseline, 6 hours after surgery, 24 hours after surgery or before discharge

Postoperative pain scores

Pain was assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating more severe pain.

Time frame: immediately after surgery and one first day after surgery

Sleep quality scores on postoperative day 1 and day 2

Sleep quality was assessed using the Richards Campbell Sleep Questionnaire (RCSQ), RCSQ uses a visual analog scale ranging from 0 to 100 for each item, where 0 represents the worst possible sleep condition (or the most negative description) and 100 represents the best possible sleep condition (or the most positive description). Patients are asked to place a slider at the position that best describes their sleep status the previous night. The total RCSQ sleep score is calculated as the mean of the first five items (Items 6-10). The sixth item (Item 11) assesses noise level and is scored separately.

Time frame: baseline, 1 day after surgery, 2day after surgery

Length of hospital stay

Time frame: Through patients discharge, an average of 2 days after surgery

Hospitalization costs

Time frame: Through patients discharge, an average of 2 days after surgery

Quality of life scores at 4 and 12 weeks 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: Baseline, 4 and 12 weeks after surgery

Quality of life scores at 4 and 12 weeks 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: Baseline, 4 and 12 weeks after surgery

Acute adverse reactions

drug reaction

Time frame: from intervention to 6 hours after surgery

Intraoperative hypotension

Systolic blood pressure \<90 mmHg or \>30% decrease from baseline

Time frame: From intervention to end of surgery

Incidence of intraoperative hypoxemia

Oxygen saturation \<90% lasting at least 30 seconds

Time frame: From intervention to end of surgery

Incidence of severe bradycardia

Heart rate \<50 beats/min

Time frame: From intervention to 6 hours after surgery

Utilization rate of vasoactive drugs

atropine, ephedrine/norepinephrine

Time frame: From intervention to 6 hours after surgery

Use Dexmedetomidine To Protect Myocardial Injury Evaluation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts