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NCT Number: NCT06154395

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location status: Recruiting

Location contact

Bo Yu, MD,PhD

CONTACT

[email protected]

+8645186605180

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Clinical Exclusion Criteria:

  • 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.

Imaging Exclusion Criteria (Visual Estimation):

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

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

    Time frame: Three days after percutaneous coronary intervention (PCI)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xingtao Huang, MD

CONTACT

[email protected]

+86-13796626722

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 4, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.