A Comparative Study of 60 MHz HD-IVUS, OCT, and Conventional Angiography to Guide Reperfusion Therapy for Improving Myocardial Microcirculation Dysfunction After Acute Anterior Myocardial Infarction

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Clinical Inclusion Criteria:

• Subjects aged ≥18 years;

• Initial diagnosis of anterior wall ST-segment elevation myocardial infarction, with symptoms occurring within 6 hours, and undergoing primarypercutaneous coronary intervention (PCI);

• Subjects (or legal representatives) who understand the study requirements and treatment procedures and provide signed informed consent.

⁃ Imaging Inclusion Criteria (Visual Estimation):

• Target lesion is the culprit lesion, located in the native coronary artery, with a visually estimated reference vessel diameter (RVD) between 2.25 mm and 4.0 mm;

• Culprit segment of the infarct-related artery (IRA) is located between the origin of the left anterior descending (LAD) artery and the emergence of the second diagonal branch (D2);

• After pre-treatment , the degree of stenosis in the LAD is ≤90%, and TIMI flow is grade 3.

Locations
Other Locations
China
The 2nd Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Contact Information
Primary
Xingtao Huang, MD
dr_huangxingtao@163.com
+86-13796626722
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 90
Treatments
Experimental: OCT-guided group
Experimental: 60 MHz HD-IVUS-guided group
Active_comparator: Angiography-guided group
Sponsors
Leads: Harbin Medical University

This content was sourced from clinicaltrials.gov