Nose spray before stent surgery may shield heart
NCT ID NCT07549282
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests whether a medicine given as a nose spray before a heart stent procedure can reduce heart muscle injury or heart attack. About 1800 adults scheduled for elective stent placement will receive either the medicine or a placebo spray. Researchers will measure heart damage through blood tests and track any heart problems for 30 days after the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
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