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NCT Number: NCT04912518

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

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%).

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Key information

Conditions

ST-segment Elevation Myocardial Infarction (STEMI) Cardioprotection Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine (DEX)

Drug

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)

Drug

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.

Primary outcomes

  1. Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.

    Time frame: 5±2 days post-STEMI

    MIS was measured by CMR delayed gadolinium enhancement（expressed as %LV myocardial mass).

Secondary outcomes

  1. Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI.

    Time frame: 5±2 days post-STEMI

    MSI defined as: (area at risk - myocardial infarct size) / area at risk × 100.

  2. Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.

    Time frame: 5±2 days post-STEMI

    MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.

  3. Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI.

    Time frame: 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.

  4. The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB).

    Time frame: 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

    Myocardial ischemic injury markers refer to CK-MB and cTnI

  5. The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB).

    Time frame: 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

    Myocardial ischemic injury markers refer to CK-MB and cTnI

  6. LVEF evaluated by echocardiograhy at 30 days post-STEMI.

    Time frame: 30 days post-STEMI

    LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.

  7. Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure.

    Time frame: 30 days and 12 months post-STEMI

    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.

Other outcomes

  1. The major prespecified safety endpoint: a composite of cardiac death during the first 24 hours after admission.

    Time frame: The first 24 hours after admission

    A composite of cardiac death was defined death from cardiac causes

  2. The major prespecified safety endpoint: II-III degree atrioventricular block during the first 24 hours after admission.

    Time frame: 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.

  3. The major prespecified safety endpoint:severe sinus bradycardia during the first 24 hours after admission.

    Time frame: The first 24 hours after admission

    Severe sinus bradycardia was defined as heart rate (HR) sustained <50 beats/min

  4. The major prespecified safety endpoint:severe hypotension during the first 24 hours after admission.

    Time frame: The first 24 hours after admission

    severe hypotension was defined as continuous systolic blood pressure <80mmHg

  5. The major prespecified safety endpoint:malignant ventricular arrhythmia during the first 24 hours after admission.

    Time frame: The first 24 hours after admission

    malignant ventricular arrhythmia including ventricular tachycardia and ventricular fibrillation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiannan Dai, M.D., Ph.D

CONTACT

[email protected]

+86 15124559838

Jinfeng Tan, M.D.

CONTACT

[email protected]

+86 13633643383

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Collaborators

  • Yangtze River Pharmaceutical Group Co., Ltd.

Registry information

Official study title

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

Acronym: COOPERATION

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 3, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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