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โ† Trials
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Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction

RecruitingNAAges 18 Years - 75 YearsAllHarbin Medical University
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In plain words

What the trial is, and whether it could suit you

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 5ยฑ2 days post-STEMI. Based on a superiority design and

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ0.2 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.
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What it tests

  • Dexmedetomidine (DEX)
  • Placebo (Saline)
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Where

9 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Mudanjiang Cardiovascular Hospital
Mudanjiang, China
Henan Provincial People's Hospital
Zhengzhou, China
Wuhan Asia Heart Hospital
Wuhan, China
Shaanxi Provincial People's Hospital
Xi'an, China
Shanxi Cardiovascular Hospital
Taiyuan, China

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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