NCT04912518 Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
| NCT ID | NCT04912518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Harbin Medical University |
| Condition | ST-segment Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-05-27 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2021-05-27 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).
Eligibility Criteria
Inclusion Criteria: the enrolled subjects must meet all of the following criteria: * Aged 18-75 years old (inclusive); * Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4); * Sign the informed consent form. Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study: * Ventricular fibrillation, cardiogenic shock, Killip III-IV grade; * Sinus bradycardia (heart rate sustained \<60 beats/min), PR interval\> 240ms or II-III degree atrioventricular block; * Continuous systolic blood pressure \<120mmHg; * Severe breathing difficulties, aterial blood oxygen saturation \<92%; * Thrombolytic therapy has been performed before the first medical contact in the hospital; * Consciousness disorder or past cerebrovascular disease; * Previous history of myocardial infarction or PCI/CABG treatment; * Known severe liver and kidney dysfunction; * Known allergy to dexmedetomidine; * CMR contraindications: such as claustrophobia, pacemaker or ICD implantation; * Pregnant or lactating women; * Malignant tumor or expected survival time \<1 year; * Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up); * Participate in other randomized controlled studies at the same time.
Contact & Investigator
Bo Yu, M.D., FACC
PRINCIPAL INVESTIGATOR
The Second Affiliated Hospital of Harbin Medical University
Frequently Asked Questions
Who can join the NCT04912518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying ST-segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04912518 currently recruiting?
Yes, NCT04912518 is actively recruiting participants. Contact the research team at daijiannandr@163.com for enrollment information.
Where is the NCT04912518 trial being conducted?
This trial is being conducted at Hefei, China, Lanzhou, China, Harbin, China, Mudanjiang, China and 5 additional locations.
Who is sponsoring the NCT04912518 clinical trial?
NCT04912518 is sponsored by Harbin Medical University. The principal investigator is Bo Yu, M.D., FACC at The Second Affiliated Hospital of Harbin Medical University. The trial plans to enroll 250 participants.