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

NCT04912518 | Recruiting DMC

• 1 other identifier: COOPERATION
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 9

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%).

Conditions

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

Keywords

ST-segment Elevation Myocardial Infarction (STEMI); Percutaneous coronary intervention; Dexmedetomidine; Cardioprotection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  5±2 days post-STEMI

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

  5±2 days post-STEMI

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

  5±2 days post-STEMI

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

  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

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

  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

Other Outcomes (5)

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

  The first 24 hours after admission

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

  The first 24 hours after admission

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

  The first 24 hours after admission

Study Arms (2)

Dexmedetomidine (DEX) group

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine (DEX)

Placebo (Saline) group

PLACEBO COMPARATOR

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.

Drug: Placebo (Saline)

Interventions

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.

Dexmedetomidine (DEX) group

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.

Placebo (Saline) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbin Medical University: lead
• Yangtze River Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (9)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

The First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, 1570011, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 30001, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

RECRUITING

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bo Yu, M.D., FACC

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Xi Su

  Wuhan Asia Heart Hospital

  PRINCIPAL INVESTIGATOR

• Xiaohui Zheng

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Kai Liu

  Mudanjiang cardiovascular hospital

  PRINCIPAL INVESTIGATOR

• Jian An

  Shanxi Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

• Xiling Shou

  Shaanxi Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Chengzhi Lu

  Tianjin First Central Hospital

  PRINCIPAL INVESTIGATOR

• Xianhe Lin

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Zheng Zhang

  LanZhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiannan Dai, M.D., Ph.D

CONTACT

+86 15124559838; daijiannandr@163.com

Jinfeng Tan, M.D.

CONTACT

+86 13633643383; 418904005@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 3, 2021
• Study Start: May 27, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)