Coronary Heart DiseasePRIMENCT07847580
Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions
A study testing Intranasal dexmedetomidine and Normal Saline in people with Coronary Heart Disease and Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to determine the effect of pre-operative dexmedetomidine on periprocedural myocardial injury in patients having percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Coronary Artery Disease
- What is being tested?
- Intranasal dexmedetomidine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 45-85 years(inclusive);
- Able to confirm understanding of risks, benefits, and treatment alternatives of receiving intranasal dexmedetomidine, and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
- Diagnosed with coronary artery disease with objective evidence of ischemia or silent ischemia, meeting the indications for elective PCI.
- Designated American Society of Anesthesiologists (ASA) physical status II-Ⅲ (ranging from mild systemic disease to severe underlying conditions; patients with marked limitation in ordinary physical activity, yet still capable of light daily activities).
Who cannot join
- Allergy or contraindication to dexmedetomidine, including severe sinus bradycardia (resting heart rate < 50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker implantation;
- Patients with severe cardiac insufficiency (left ventricular ejection fraction < 40% or New York Heart Association functional class Ⅲ-IV), cardiogenic shock, or hemodynamic instability;
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure < 90 mmHg);
- BMI > 30 kg/m²;
- Known or suspected sleep apnea;
- Use of drugs that may interfere with the study medication within 1 week before surgery, including α2-adrenergic receptor agonists (e.g., clonidine) or antagonists, and tricyclic antidepressants;
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- Language, visual, or hearing impairment that may affect questionnaire assessment;
- Hepatic or renal insufficiency (Alanine Aminotransferase/Aspartate Aminotransferase/Creatinine > 3 times the upper limit of normal);
- Nasal anatomical abnormalities interfering with nasal spray administration;
- Pregnant or lactating women;
- Participation in another clinical trial that may conflict with this trial.
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Prospective, Multi-Center Randomized Trial
The goal of this clinical trial is to determine the effect of pre-operative dexmedetomidine on periprocedural myocardial injury in patients having percutaneous coronary intervention (PCI). The specific research hypothesis is that intranasal administration of 100 μg dexmedetomidine (DEX) reduces the incidence of periprocedural myocardial injury within 48 hours after PCI, as compared with normal saline.
Participants will be randomly assigned in a 1:1 ratio to two groups: the dexmedetomidine group and the placebo group.
- Conditions
- Coronary Heart Disease, Coronary Artery Disease
- Being tested
- Intranasal dexmedetomidine, Normal Saline
- Keywords
- Intranasal Dexmedetomidine, Perioperative Myocardial Injury, Percutaneous Coronary Interventions
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
Patients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril).
Normal SalineDrug
Patients will receive an equal volume of intranasal normal saline containing no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal DEX group | Experimental | Patients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril). Receives: Drug: Intranasal dexmedetomidine |
| Placebo group | Placebo comparator | Patients will receive an equal volume of intranasal normal saline containing no active ingredient 60 ± 10 minutes before the procedure. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury occurring within 48 hours after surgery
In patients with a normal baseline cardiac troponin (cTn, whether non-high sensitivity cTnT or cTnI) 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: Within 48 hours after surgery
Secondary outcomes (3)
Delirium within the first postoperative day
The 3D-CAM scale will be used to evaluate participants for postoperative delirium.
Measured: Within the first postoperative day
Acute kidney injury in 48 hours after PCI
An absolute increase in serum creatinine of ≥0.3 mg/dL within 48 hours after PCI, or a relative increase in serum creatinine of ≥50% within 7 days after PCI
Measured: Within 48 hours after PCI.
A collapsed (one or more) composite of serious cardiovascular complications within 30 days after PCI
Components of the composite are: (1) myocardial infarction; (2) new-onset stroke or transient ischemic attack (TIA); (3) all-cause mortality; (4) any unplanned repeat revascularization; (5) arrhythmias requiring electrical or pharmacological treatment.
Measured: Within 30 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Jul 2029 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847580
- Sponsor's protocol ID
- 2026-1404
- Acronym
- PRIME
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Prospective, Multi-Center Randomized Trial
- ClinicalTrials.gov ID
- NCT07847580
- Acronym / sponsor ID
- PRIME / 2026-1404
- Conditions
- Coronary Heart Disease, Coronary Artery Disease
- Keywords
- Intranasal Dexmedetomidine, Perioperative Myocardial Injury, Percutaneous Coronary Interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the effect of pre-operative dexmedetomidine on periprocedural myocardial injury in patients having percutaneous coronary intervention (PCI). The specific research hypothesis is that intranasal administration of 100 μg dexmedetomidine (DEX) reduces the incidence of periprocedural myocardial injury within 48 hours after PCI, as compared with normal saline.
Participants will be randomly assigned in a 1:1 ratio to two groups: the dexmedetomidine group and the placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal DEX group | Experimental | Drug: Intranasal dexmedetomidinePatients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril). |
| Placebo group | Placebo comparator | Drug: Normal SalinePatients will receive an equal volume of intranasal normal saline containing no active ingredient 60 ± 10 minutes before the procedure. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 45-85 years(inclusive);
- Able to confirm understanding of risks, benefits, and treatment alternatives of receiving intranasal dexmedetomidine, and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
- Diagnosed with coronary artery disease with objective evidence of ischemia or silent ischemia, meeting the indications for elective PCI.
- Designated American Society of Anesthesiologists (ASA) physical status II-Ⅲ (ranging from mild systemic disease to severe underlying conditions; patients with marked limitation in ordinary physical activity, yet still capable of light daily activities).
Key exclusion criteria (11 listed)
- Allergy or contraindication to dexmedetomidine, including severe sinus bradycardia (resting heart rate < 50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker implantation;
- Patients with severe cardiac insufficiency (left ventricular ejection fraction < 40% or New York Heart Association functional class Ⅲ-IV), cardiogenic shock, or hemodynamic instability;
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure < 90 mmHg);
- BMI > 30 kg/m²;
- Known or suspected sleep apnea;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal dexmedetomidinePatients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril). | Drug | Intranasal DEX group |
| Normal SalinePatients will receive an equal volume of intranasal normal saline containing no active ingredient. | Drug | Placebo group |
Primary outcome
Myocardial injury occurring within 48 hours after surgery
Time frame: Within 48 hours after surgery
In patients with a normal baseline cardiac troponin (cTn, whether non-high sensitivity cTnT or cTnI) 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
3 secondary outcomes
Delirium within the first postoperative day
Time frame: Within the first postoperative day
Acute kidney injury in 48 hours after PCI
Time frame: Within 48 hours after PCI.
A collapsed (one or more) composite of serious cardiovascular complications within 30 days after PCI
Time frame: Within 30 days after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal dexmedetomidine and Normal Saline in people with Coronary Heart Disease and Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Yan, Doctor (15888210247, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury occurring within 48 hours after surgery (time frame: Within 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.