[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658071":3},{"organization":4,"outcomesModule":7,"designInfo":70,"detailedDescription":73,"studyPopulation":73,"armGroups":82,"interventions":95,"overallOfficials":73,"centralContacts":104,"locations":110,"responsibleParty":123,"collaborators":73,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":73,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":150,"whyStopped":73,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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","Within 48 hours after surgery",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Delirium within the first postoperative day","The 3D-CAM scale will be used to evaluate participants for postoperative delirium.","Within the first postoperative day",{"measure":19,"description":20,"timeFrame":21},"Acute kidney injury in 48 hours after PCI","An absolute increase in serum creatinine of ≥0.3 mg\u002FdL within 48 hours after PCI, or a relative increase in serum creatinine of ≥50% within 7 days after PCI","Within 48 hours after PCI.",{"measure":23,"description":24,"timeFrame":25},"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.","Within 30 days after PCI",[27,31,35,39,43,47,50,54,58,61,64,67],{"measure":28,"description":29,"timeFrame":30},"Postoperative first-night sleep quality","Sleep quality during the surgical night will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the morning of postoperative day 1.This scale consists of 6 dimensions, each scored on a scale of 0 to 100, with higher scores indicating better sleep quality.","Postoperative day 1.",{"measure":32,"description":33,"timeFrame":34},"Perioperative anxiety score","Peri-operative anxiety status will be assessed with the Perioperative Anxiety Scale-7 (PAS-7). This scale consists of 7 dimensions, each scored on a scale of 0 to 4, with higher scores indicating more severe anxiety symptoms.","From study drug administration to 6 hours after PCI.",{"measure":36,"description":37,"timeFrame":38},"Peak postoperative cardiac troponin","Marker values will be standardised (multiples of the upper-reference-limit, ×URL) according to different types of cardiac biomarkers.","Within 48 hours after PCI",{"measure":40,"description":41,"timeFrame":42},"Intraoperative pain score","Pain intensity assessed immediately post-procedure by Numeric Rating Scale（NRS）. This scale is scored on a scale of 0 to 10, with higher scores indicating more severe pain.","Immediately post-procedure.",{"measure":44,"description":45,"timeFrame":46},"The EuroQol Five-Dimensional Questionnaire (EQ-5D) scores at 30 days after PCI","Assessed by the EuroQol Five-Dimensional Questionnaire (EQ-5D) at 30 days post-PCI.\n\nThe EQ-5D comprises 5 dimensions and a visual analogue scale. Each dimension is rated at 5 levels. The EuroQol visual analogue scale (EQ-VAS) requires patients to rate their current overall health on a 0-100 visual analogue scale, where 0 represents the worst health state imaginable and 100 represents the best health state imaginable.","At 30 days post-PCI.",{"measure":48,"description":49,"timeFrame":46},"The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores at 30 days after PCI","The KCCQ comprises 23 items across 7 domains, each scored on a scale of 0 to 100, with higher scores indicating better health status.",{"measure":51,"description":52,"timeFrame":53},"Acute adverse reactions","Acute adverse reactions include allergy, dizziness, nausea, vomiting, and other related manifestations.","Within the period from drug administration to 6 hours after surgery",{"measure":55,"description":56,"timeFrame":57},"Hypotension","A mean arterial pressure (MAP) below 65 mmHg or a reduction of more than 30% from baseline.","Within the period from drug administration to 6 hours after surgery.",{"measure":59,"description":60,"timeFrame":57},"Severe bradycardia","A heart rate below 40 beats per minute.",{"measure":62,"description":63,"timeFrame":57},"Hypoxemia","An oxygen saturation below 90% lasting for at least 30 seconds.",{"measure":65,"description":66,"timeFrame":57},"Dosage of vasoactive agents","Vasoactive agents includes atropine, norepinephrine, and nitroglycerin.",{"measure":68,"description":69,"timeFrame":57},"Local nasal adverse reactions","Local nasal adverse reactions: including nasal discomfort, irritation, nasal congestion, rhinorrhoea, epistaxis, dysgeusia, and incomplete delivery of study nasal-spray medication.",{"allocation":71,"interventionModel":72,"interventionModelDescription":73,"primaryPurpose":74,"observationalModel":73,"timePerspective":73,"maskingInfo":75},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":76,"maskingDescription":73,"whoMasked":77},"QUADRUPLE",[78,79,80,81],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"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).",[88],"Drug: Intranasal dexmedetomidine",{"label":90,"type":91,"description":92,"interventionNames":93},"Placebo group","PLACEBO_COMPARATOR","Patients will receive an equal volume of intranasal normal saline containing no active ingredient 60 ± 10 minutes before the procedure.",[94],"Drug: Normal Saline",[96,100],{"type":97,"name":98,"description":86,"armGroupLabels":99,"otherNames":73},"DRUG","Intranasal dexmedetomidine",[84],{"type":97,"name":101,"description":102,"armGroupLabels":103,"otherNames":73},"Normal Saline","Patients will receive an equal volume of intranasal normal saline containing no active ingredient.",[90],[105],{"name":106,"role":107,"phone":108,"phoneExt":73,"email":109},"Min Yan, Doctor","CONTACT","15888210247","zryanmin@zju.edu.cn",[111],{"facility":112,"status":73,"city":113,"state":114,"zip":73,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":73},"The Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","China","CN",{"type":118,"coordinates":119},"Point",[120,121],120.16142,30.29365,{"lat":121,"lon":120},{"type":124,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":73,"oldNameTitle":73,"oldOrganization":73},"SPONSOR","100658071","intranasal-dexmedetomidine-and-perioperative-myocardial-injury-in-patients-having-percutaneous-coronary-interventions-100658071",false,"NCT07847580","Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions","Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Prospective, Multi-Center Randomized Trial","PRIME","Inclusion Criteria:\n\n* Aged 45-85 years(inclusive);\n* Able to confirm understanding of risks, benefits, and treatment alternatives of receiving intranasal dexmedetomidine, and he\u002Fshe or his\u002Fher legally authorized representative provides written informed consent prior to any study-related procedure.\n* Diagnosed with coronary artery disease with objective evidence of ischemia or silent ischemia, meeting the indications for elective PCI.\n* 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).\n\nExclusion Criteria:\n\n* Allergy or contraindication to dexmedetomidine, including severe sinus bradycardia (resting heart rate \\\u003C 50 beats\u002Fmin), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker implantation;\n* Patients with severe cardiac insufficiency (left ventricular ejection fraction \\\u003C 40% or New York Heart Association functional class Ⅲ-IV), cardiogenic shock, or hemodynamic instability;\n* Uncontrolled hypertension (systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg) or hypotension (systolic blood pressure \\\u003C 90 mmHg);\n* BMI \\> 30 kg\u002Fm²;\n* Known or suspected sleep apnea;\n* 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;\n* Language, visual, or hearing impairment that may affect questionnaire assessment;\n* Hepatic or renal insufficiency (Alanine Aminotransferase\u002FAspartate Aminotransferase\u002FCreatinine \\> 3 times the upper limit of normal);\n* Nasal anatomical abnormalities interfering with nasal spray administration;\n* Pregnant or lactating women;\n* Participation in another clinical trial that may conflict with this trial.","ALL","45 Years","85 Years",{"count":137,"type":138},2500,"ESTIMATED","INTERVENTIONAL",[141],"NA","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.\n\nParticipants will be randomly assigned in a 1:1 ratio to two groups: the dexmedetomidine group and the placebo group.",[144,145],"Coronary Heart Disease","Coronary Artery Disease",[147,148,149],"Intranasal Dexmedetomidine","Perioperative Myocardial Injury","Percutaneous Coronary Interventions","NOT_YET_RECRUITING","2026-09-23",{"date":153,"type":154},"2026-09-29","ACTUAL",{"date":156,"type":138},"2026-09-30",{"date":158,"type":138},"2029-07-31",{"name":5,"class":6},1]