Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04912518

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

Led by Harbin Medical University · Updated on 2024-10-15

250

Participants Needed

9

Research Sites

52 weeks

Total Duration

On this page

Sponsors

H

Harbin Medical University

Lead Sponsor

Y

Yangtze River Pharmaceutical Group Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of dexmedetomidine (DEX) on heart damage size in patients who have experienced an anterior ST-segment elevation myocardial infarction (STEMI) and are undergoing primary percutaneous coronary intervention (pPCI) within 6 hours of symptom onset. This double-blind, randomized, placebo-controlled trial aims to determine if DEX can reduce myocardial infarct size compared to a placebo. The trial plans to enroll 250 patients to achieve reliable results. Participants are randomly assigned to either the DEX group or the placebo group in a 1:1 ratio. Those in the DEX group receive an intravenous infusion starting immediately upon enrollment, with doses adjusted between 0.2 to 0.7 µg/kg/h based on heart rate, blood pressure, and sedation scores, continuing throughout the PCI procedure. The placebo group receives saline infusions following the same schedule and dose adjustments. This treatment phase occurs during the PCI operation. During the study, patients undergo cardiac magnetic resonance imaging (CMR) about 5 days after STEMI to measure myocardial infarct size and other heart function indicators. Additional evaluations include blood tests for heart damage markers at multiple time points after PCI and echocardiography at 30 days. Researchers track major adverse cardiovascular events up to 12 months post-STEMI. Total participation includes initial treatment and follow-up assessments over one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-75 years old (inclusive)
  • Diagnosed with anterior STEMI within 6 hours of symptom onset, confirmed by ischemic chest discomfort and specific ECG changes
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Ventricular fibrillation, cardiogenic shock, or Killip class III-IV heart failure
  • Sinus bradycardia with heart rate under 60 beats per minute, prolonged PR interval over 240ms, or second to third degree atrioventricular block
  • Continuous systolic blood pressure below 120 mmHg
  • Severe breathing difficulties or arterial blood oxygen saturation below 92%
  • Thrombolytic therapy before first medical contact
  • Consciousness disorder or past stroke
  • Previous myocardial infarction or PCI/CABG treatment
  • Known severe liver or kidney dysfunction
  • Allergy to dexmedetomidine
  • Contraindications to cardiac MRI such as claustrophobia or implanted pacemaker/ICD
  • Pregnant or lactating women
  • Malignant tumor or expected survival less than 1 year
  • Any condition making participation unsafe or unsuitable, including poor compliance
  • Participation in other randomized controlled trials at the same time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 48 hours post-PCI procedure

Participants receive intravenous infusion of dexmedetomidine or placebo immediately after enrollment. Dosage is adjusted based on heart rate, blood pressure, and sedation score.

Multiple assessments including before drug administration and at 6, 12, 24, and 48 hours after PCI procedure

Follow-up

Duration - Up to 12 months post-STEMI

Participants undergo cardiac magnetic resonance imaging (CMR) and echocardiography to evaluate heart function and myocardial injury, and are monitored for major adverse cardiovascular events.

Visits at approximately 5 days, 30 days, and 12 months post-STEMI

Trial Site Locations

Total: 9 locations

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230000

Actively Recruiting

2

The First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China, 730000

Actively Recruiting

3

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150000

Actively Recruiting

4

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, China, 1570011

Actively Recruiting

5

Henan Provincial People's Hospital

Zhengzhou, Henan, China, 450000

Actively Recruiting

6

Wuhan Asia Heart Hospital

Wuhan, Hubei, China, 430022

Actively Recruiting

7

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China, 710068

Actively Recruiting

8

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China, 30001

Actively Recruiting

9

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China, 300192

Actively Recruiting

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Research Team

J

Jiannan Dai, M.D., Ph.D

J

Jinfeng Tan, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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