Use Dexmedetomidine To Protect Myocardial Injury Evaluation

NCT07549282 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-0521
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Heart Disease; Myocardial Injury; Dexmedetomidine; Myocardial Infarction

Outcome Measures

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

  from the end of surgery to 48 hours after surgery

Secondary Outcomes (19)

• Incidence of perioperative myocardial injury

  from the end of surgery to 48 hours after surgery

• Incidence of perioperative myocardial infarction

  from the end of surgery to 48 hours after surgery

• Incidence of severe perioperative myocardial injury

  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

  4 and 12 weeks after surgery

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

  4 and 12 weeks after surgery

Other Outcomes (3)

• Incidence of MACCE at 1 year after surgery

  1 year after surgery

• Quality of life scores at 1 year after surgery

  1 year after surgery

• Quality of life scores at 1 year after surgery

  1 year after surgery

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

The subjects received intranasal dexmedetomidine (100 μg, sprayed equally into both nostrils, two sprays per nostril) 15 minutes before surgery in the preoperative preparation area.

Drug: Intranasal Dexmedetomidine

Normal saline Group

PLACEBO COMPARATOR

The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

Drug: Normal saline

Interventions

Intranasal Dexmedetomidine DRUG

The subjects received intranasal dexmedetomidine (100 μg, sprayed equally into both nostrils, two sprays per nostril) 15 minutes before surgery in the preoperative preparation area.

Dexmedetomidine Group

Normal saline DRUG

The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

Normal saline Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Disease; Myocardial Infarction

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Min Yan, Doctor

CONTACT

15888210247; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-03

Locations

CN (1)