Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06154395

Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction

Led by Harbin Medical University · Updated on 2024-10-18

90

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a prospective, single-center, randomized controlled clinical trial. Ninety patients with anterior wall ST-segment elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (PCI) within 6 hours of symptom onset will be screened. Patients with inclusion criteria and without exclusion criteria will be randomized into three groups in a 1:1:1 ratio: OCT-guided group, 60 MHz HD-IVUS-guided group, and angiography-guided group after signing the informed consent form. Based on the lesion characteristics detected by imaging in each group, coronary revascularization will be performed for the culprit vessels of myocardial infarction. The TIMI myocardial perfusion frame count (TMPFC) values of the culprit vessels will be recorded immediately after PCI, and secondary prevention medications for myocardial infarction will be administered. Three days after the procedure, a 3.0T cardiac magnetic resonance imaging (MRI) with gadolinium diethylenetriaminepentaacetic acid (Gd-DTPA) delayed enhancement (LEG) scan will be conducted to assess the microvascular obstruction (MVO) area. Patients will be followed in the outpatient clinic visit at 1 month (with a window period of XX days) after discharge, and a repeat cardiac MRI will be performed to determine the presence of MVO and the size of the myocardial infarction.

CONDITIONS

Official Title

Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Initial diagnosis of anterior wall ST-segment elevation myocardial infarction with symptom onset within 6 hours
  • Planned for primary percutaneous coronary intervention (PCI)
  • Signed informed consent from patient or legal representative
  • Target lesion is the culprit lesion in native coronary artery with estimated reference vessel diameter between 2.25 mm and 4.0 mm
  • Culprit lesion located between the origin of the left anterior descending artery and the second diagonal branch
  • After pre-treatment, stenosis in the left anterior descending artery is 90% or less, and TIMI flow grade is 3
Not Eligible

You will not qualify if you...

  • History of coronary artery bypass grafting (CABG)
  • Previous myocardial infarction or PCI
  • Received thrombolytic therapy before PCI
  • Severe liver or kidney dysfunction, severe valvular heart disease, or chronic obstructive pulmonary disease
  • Contraindications to magnetic resonance imaging
  • Allergy to gadolinium contrast agents or medications related to devices or procedures
  • Expected lifespan less than 12 months
  • Pregnant or lactating females
  • Other conditions that investigator deems unsuitable for study participation
  • Lesions requiring intervention other than the target lesion at baseline surgery
  • Left main coronary artery disease with stenosis over 50%
  • Diffuse severe calcification over 20 mm or chronic total occlusion in major coronary vessels
  • Severe coronary artery tortuosity over 45 degrees or calcification over 270 degrees, or other conditions interfering with intravascular imaging

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Actively Recruiting

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Research Team

X

Xingtao Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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