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

October 16, 2024 updated by: Yu Bo, Harbin Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Clinical Inclusion Criteria:

  1. Subjects aged ≥18 years;
  2. Initial diagnosis of anterior wall ST-segment elevation myocardial infarction, with symptoms occurring within 6 hours, and undergoing primarypercutaneous coronary intervention (PCI);
  3. Subjects (or legal representatives) who understand the study requirements and treatment procedures and provide signed informed consent.

Imaging Inclusion Criteria (Visual Estimation):

  1. 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;
  2. 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);
  3. After pre-treatment , the degree of stenosis in the LAD is ≤90%, and TIMI flow is grade 3.

Exclusion Criteria:

Clinical Exclusion Criteria:

  1. History of coronary artery bypass grafting (CABG);
  2. Known history of myocardial infarction or PCI;
  3. Previous thrombolytic therapy before PCI;
  4. Severe liver or kidney dysfunction, severe valvular heart disease, chronic obstructive pulmonary disease, etc.;
  5. Contraindications to magnetic resonance imaging;
  6. 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);
  7. Expected lifespan of the subject less than 12 months;
  8. Pregnant or lactating females;
  9. Other subjects deemed unsuitable for participation in the study by the investigator.

Imaging Exclusion Criteria (Visual Estimation):

  1. Presence of lesions requiring intervention other than the target lesion at baseline surgery;
  2. No protected left main coronary artery disease (visual estimate of stenosis >50%);
  3. Diffuse severe calcification (>20 mm) or chronic total occlusion in the major coronary vessels (LCX, RCA);
  4. Severe coronary artery tortuosity (>45°) or calcification (>270°), or other conditions that may interfere with the use of intravascular imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT-guided group
Procedure: OCT-guided PCI
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.
Experimental: 60 MHz HD-IVUS-guided group
Procedure: 60 MHz HD-IVUS-guided PCI
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.
Active Comparator: Angiography-guided group
Procedure: Angiography-guided PCI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Three days after percutaneous coronary intervention (PCI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Investigators

  • Principal Investigator: Bo Yu, M.D.; Ph.D., The Second Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 23, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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