Use Dexmedetomidine To Protect Myocardial Injury Evaluation

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07549282
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Coronary Heart Disease
  • Dexmedetomidine
  • Myocardial Infarction
  • Myocardial Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

First listed
Apr 24, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dexmedetomidine Group
    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.
  • Placebo Comparator: Normal saline Group
    The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

Primary Outcome Measure

Composite incidence of perioperative myocardial injury and myocardial infarction [ Time Frame: from the end of surgery to 48 hours after surgery ]

Central Contacts

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