Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction

Percutaneous Coronary Intervention Clinical Trial

— COOPERATION  

Official title:

Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912518
• Other study ID #: COOPERATION
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Harbin Medical University
• Contact: Jiannan Dai, M.D., Ph.D
• Phone: +86 15124559838
• Email: daijiannandr[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardioprotection
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Lanzhou University	Lanzhou	Gansu
China	Mudanjiang Cardiovascular Hospital	Mudanjiang	Heilongjiang
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Harbin Medical University	Yangtze River Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The major prespecified safety endpoint: a composite of cardiac death during the first 24 hours after admission.	A composite of cardiac death was defined death from cardiac causes	The first 24 hours after admission
Other	The major prespecified safety endpoint: II-III degree atrioventricular block during the first 24 hours after admission.	Atrioventricular block is defined as the abnormal conduction of electrical activation between the atria and ventricles during the conduction of electrical activation of the heart, which can lead to arrhythmia and prevent the heart from contracting and pumping blood normally.	The first 24 hours after admission
Other	The major prespecified safety endpoint:severe sinus bradycardia during the first 24 hours after admission.	Severe sinus bradycardia was defined as heart rate (HR) sustained <50 beats/min	The first 24 hours after admission
Other	The major prespecified safety endpoint:severe hypotension during the first 24 hours after admission.	severe hypotension was defined as continuous systolic blood pressure <80mmHg	The first 24 hours after admission
Other	The major prespecified safety endpoint:malignant ventricular arrhythmia during the first 24 hours after admission.	malignant ventricular arrhythmia including ventricular tachycardia and ventricular fibrillation.	The first 24 hours after admission
Primary	Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.	MIS was measured by CMR delayed gadolinium enhancement(expressed as %LV myocardial mass).	5±2 days post-STEMI
Secondary	Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI.	MSI defined as: (area at risk - myocardial infarct size) / area at risk × 100.	5±2 days post-STEMI
Secondary	Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.	MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.	5±2 days post-STEMI
Secondary	Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI.	LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.	5±2 days post-STEMI
Secondary	The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB).	Myocardial ischemic injury markers refer to CK-MB and cTnI	First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure
Secondary	The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB).	Myocardial ischemic injury markers refer to CK-MB and cTnI	First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure
Secondary	LVEF evaluated by echocardiograhy at 30 days post-STEMI.	LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.	30 days post-STEMI
Secondary	Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure.	Clinical follow-up is performed at 30 days, 3 months, 6 months, and 12 months. Follow-up at 30 days is in the outpatient clinic, other time frame follow-up is performed by phone call and clinical charts review.	30 days and 12 months post-STEMI