Not Yet RecruitingPhase 4

Use Dexmedetomidine To Protect Myocardial Injury Evaluation

China1,800 participantsStarted 2026-04

Plain-language summary

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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing whether dexmedetomidine can reduce heart muscle injury during surgery in people with coronary heart disease — given that it's a Phase 4 study, what does that mean for how much is already known about dexmedetomidine's safety compared to earlier-phase trials?
2The trial is listed as 'not yet recruiting,' so if this might be a good fit for me, how soon do you expect it to open, and should I be doing anything now to prepare or stay on a standard treatment path in the meantime?
3The trial is measuring a 'composite' outcome of both perioperative myocardial injury and myocardial infarction — can you explain what that means for me specifically, and how my own risk of those events during surgery would factor into whether a trial like this makes sense?
4Are there standard-of-care options already available to protect my heart during surgery that I should consider first, or would participating in this trial be compatible with those approaches?
5What would my involvement in this trial actually look like day-to-day — for example, how would dexmedetomidine be given, how long would I need to be monitored, and how does that fit with my overall surgical and recovery plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite incidence of perioperative myocardial injury and myocardial infarction

Timeframe: from the end of surgery to 48 hours after surgery

Trial details

NCT IDNCT07549282

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Min Yan, Doctor

15888210247 zryanmin@zju.edu.cn

View on ClinicalTrials.gov More Coronary Heart Disease trials