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

NCT06154395 | Recruiting

• 1 other identifier: KY2023-137
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intravascular Imaging and Microvascular Obstruction

Outcome Measures

Primary Outcomes (1)

• Microvascular obstruction (MVO) assessed by cardiac magnetic resonance imaging (CMR)

  The area of microvascular obstruction (MVO) assessed by cardiac magnetic resonance imaging (CMR) three days after percutaneous coronary intervention (PCI).

  Three days after percutaneous coronary intervention (PCI)

Study Arms (3)

OCT-guided group

EXPERIMENTAL

Procedure: OCT-guided PCI

60 MHz HD-IVUS-guided group

EXPERIMENTAL

Procedure: 60 MHz HD-IVUS-guided PCI

Angiography-guided group

ACTIVE COMPARATOR

Procedure: Angiography-guided PCI

Interventions

OCT-guided PCI PROCEDURE

The OCT guidance team routinely conducts OCT examinations on patients after standard angiography and/or thrombus aspiration. The OCT examination follows a standard procedure. The operator evaluates the stability of the lesion and decides whether to proceed with stent implantation therapy (with the option to choose the type of stent) or opt for conservative medical treatment. If a stent is implanted, the procedure is carried out according to guidelines and standard protocols, with the landing zone of the stent determined based on OCT image features. After stent implantation, a follow-up OCT examination of the stent segment, as well as angiographic examination, is performed. Based on the OCT results, the operator decides whether post-dilation is necessary.

OCT-guided group

60 MHz HD-IVUS-guided PCI PROCEDURE

The IVUS guidance team routinely conducts IVUS examinations on patients after standard angiography and/or thrombus aspiration. The IVUS examination follows a standard procedure. The operator evaluates the stability of the lesion and decides whether to proceed with stent implantation therapy (with the option to choose the type of stent) or opt for conservative medical treatment. If a stent is implanted, the procedure is carried out according to guidelines and standard protocols, with the landing zone of the stent determined based on IVUS image features. After stent implantation, a follow-up IVUS examination of the stent segment, as well as angiographic examination, is performed. Based on the IVUS results, the operator decides whether post-dilation is necessary.

60 MHz HD-IVUS-guided group

Angiography-guided PCI PROCEDURE

After routine angiography and/or thrombus aspiration, the operator assesses the lesion based on treatment standards to determine whether stent implantation is necessary. For patients undergoing stent implantation, a follow-up angiography is performed postoperatively, and the decision for post-dilation is made by the operator based on experience.

Angiography-guided group

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• History of coronary artery bypass grafting (CABG);
• Known history of myocardial infarction or PCI;
• Previous thrombolytic therapy before PCI;
• Severe liver or kidney dysfunction, severe valvular heart disease, chronic obstructive pulmonary disease, etc.;
• Contraindications to magnetic resonance imaging;
• Allergy to gadolinium contrast agents and/or accompanying medications for devices or procedures (e.g., any component of drug-eluting stents, all P2Y12 inhibitors, or aspirin);
• Expected lifespan of the subject less than 12 months;
• Pregnant or lactating females;
• Other subjects deemed unsuitable for participation in the study by the investigator.
• Presence of lesions requiring intervention other than the target lesion at baseline surgery;
• No protected left main coronary artery disease (visual estimate of stenosis \>50%);
• Diffuse severe calcification (\>20 mm) or chronic total occlusion in the major coronary vessels (LCX, RCA);
• Severe coronary artery tortuosity (\>45°) or calcification (\>270°), or other conditions that may interfere with the use of intravascular imaging.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

Study Officials

• Bo Yu, M.D.; Ph.D.

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingtao Huang, MD

CONTACT

+86-13796626722; dr_huangxingtao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cardiology

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: December 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CN (1)