Status:

RECRUITING

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

Lead Sponsor:

Harbin Medical University

Collaborating Sponsors:

Yangtze River Pharmaceutical Group Co., Ltd.

Conditions:

ST-segment Elevation Myocardial Infarction (STEMI)

Percutaneous Coronary Intervention

Eligibility:

All Genders

18-75 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT04912518

Start Date

May 27 2021

End Date

December 1 2025

Last Update

October 15 2024

Active Locations (9)

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Page 1 of 3 (9 locations)

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230000

2

The First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China, 730000

3

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150000

4

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, China, 1570011