Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
NCT ID: NCT04912518
Last Updated: 2024-10-15
Study Results
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Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2021-05-27
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dexmedetomidine (DEX) group
The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
Dexmedetomidine (DEX)
The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
Placebo (Saline) group
The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX group.
Placebo (Saline)
The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX.
Interventions
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Dexmedetomidine (DEX)
The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
Placebo (Saline)
The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Yangtze River Pharmaceutical Group Co., Ltd.
INDUSTRY
Harbin Medical University
OTHER
Responsible Party
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Yu Bo
Director
Principal Investigators
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Bo Yu, M.D., FACC
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Harbin Medical University
Xi Su
Role: PRINCIPAL_INVESTIGATOR
Wuhan Asia Heart Hospital
Xiaohui Zheng
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Kai Liu
Role: PRINCIPAL_INVESTIGATOR
Mudanjiang cardiovascular hospital
Jian An
Role: PRINCIPAL_INVESTIGATOR
Shanxi Cardiovascular Hospital
Xiling Shou
Role: PRINCIPAL_INVESTIGATOR
Shaanxi Provincial People's Hospital
Chengzhi Lu
Role: PRINCIPAL_INVESTIGATOR
Tianjin First Central Hospital
Xianhe Lin
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui Medical University
Zheng Zhang
Role: PRINCIPAL_INVESTIGATOR
LanZhou University
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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COOPERATION
Identifier Type: -
Identifier Source: org_study_id
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