Coronary Heart DiseasePhase 4NCT07549282
Intranasal Dexmedetomidine and Perioperative Myocardial Injury
A Phase 4 study testing Intranasal Dexmedetomidine and Normal saline in people with Coronary Heart Disease and Myocardial Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
PCI is the standard treatment for CAD, yet perioperative myocardial injury occurs frequently in nearly 40% of patients. Perioperative stress and sympathetic overactivation break myocardial oxygen balance and lead to cardiac damage, which further raises short-term cardiovascular events and long-term mortality risks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Myocardial Injury, Myocardial Infarction
- What is being tested?
- Intranasal Dexmedetomidine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Feb 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 85 years old;
- Subjects are fully informed of the risks, benefits and alternative treatment regimens of intranasal dexmedetomidine administration. Written informed consent is signed by the subject themselves or their legal representative prior to any study-related procedures;
- Confirmed diagnosis of coronary artery disease with objective evidence of myocardial ischemia or silent myocardial ischemia, and indications for elective percutaneous coronary intervention (PCI);
- American Society of Anesthesiologists (ASA) physical status classification II to III (patients with mild to severe systemic underlying diseases; ordinary physical activities are markedly limited, yet mild daily activities can be performed).
Who cannot join
- Subjects with hypersensitivity or contraindications to dexmedetomidine, including severe sinus bradycardia (resting heart rate <50 beats per minute), sick sinus syndrome, and second-degree or higher atrioventricular block without pacemaker implantation;
- Severe cardiac dysfunction (left ventricular ejection fraction <40%), New York Heart Association (NYHA) class III-IV heart failure, cardiogenic shock, or hemodynamic instability;
- Poorly controlled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), or hypotension (systolic blood pressure <90 mmHg);
- Coexisting obstructive sleep apnea hypopnea syndrome (OSAHS);
- Body mass index (BMI) >30 kg/m²;
- Use of agents that may interfere with the study drug within 1 week before surgery, including α₂ adrenergic receptor agonists (e.g., clonidine), receptor antagonists, and tricyclic antidepressants;
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- Cognitive assessment cannot be completed due to language, visual or hearing impairment;
- Hepatic or renal insufficiency (alanine aminotransferase, aspartate aminotransferase, or serum creatinine exceeding 3 times the upper limit of normal reference values);
- Nasal anatomical abnormalities that preclude intranasal spray administration;
- Pregnant or breastfeeding women;
- Participation in other conflicting clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
Official title: Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Single-Center, Prospective Randomized Controlled Pilot Study
PCI is the standard treatment for CAD, yet perioperative myocardial injury occurs frequently in nearly 40% of patients. Perioperative stress and sympathetic overactivation break myocardial oxygen balance and lead to cardiac damage, which further raises short-term cardiovascular events and long-term mortality risks. Dexmedetomidine exerts cardioprotective effects by inhibiting sympathetic excitation, though intravenous use carries risks of hypotension and bradycardia. Intranasal dexmedetomidine shows equivalent efficacy with fewer side effects and better patient compliance. Since no standard perioperative anesthesia regimen exists for elective PCI patients and the clinical benefits of dexmedetomidine remain unconfirmed, this pilot study is designed to test the feasibility and safety of intranasal dexmedetomidine spray before launching large formal RCTs.
- Being tested
- Intranasal Dexmedetomidine, Normal saline
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal DexmedetomidineDrug
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 salineDrug
The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intranasal Dexmedetomidine |
| Normal saline Group | Placebo comparator | The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative myocardial injury
Definition of myocardial injury: In patients with a normal baseline cTn concentration (≤99th percentile upper reference limit [URL]), postoperative cTn elevation exceeding the 99th percentile URL; In patients with an elevated baseline cTn concentration (>99th percentile URL) that was stable or decreasing, a postoperative cTn increase of >20% from baseline, with an absolute value exceeding the 99th percentile URL.
Measured: From the end of surgery to 48 hours after surgery
Secondary outcomes (4)
Incidence of major 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).
Measured: From the end of surgery to 48 hours after surgery
Composite outcome at 30 days after PCI
Consisting of: (1) myocardial infarction; (2) new-onset stroke or transient ischemic attack (TIA); (3) all-cause death; and (4) any unplanned revascularization.
Measured: 30 days after surgery
Blood pressure stability
Quantified by the absolute real variability of perioperative generalized mean arterial pressure (ARV-MAP). Calculation procedures are as follows:
① For continuous arterial blood pressure waveform data, calculate the mean MAP for each non-overlapping 15-minute time window.
② Compute the absolute value of the difference between the mean MAP of every pair of adjacent time windows.
③ Sum all these absolute values, then divide the total sum by the total observation duration (operative time).
A lower ARV-MAP value indicates smaller temporal fluctuations in MAP, meaning more stable blood pressure.
Measured: From the start of the procedure to the end of the procedure
Perioperative myocardial oxygen consumption
Rate-pressure product (RPP) = heart rate (beats per minute) × systolic blood pressure (mmHg). Blood pressure and heart rate are recorded every 15 minutes after patients enter the operating room, and the mean value of RPP is calculated.
Measured: From the start of the procedure to the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549282
- Sponsor's protocol ID
- 2026-1148
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No