Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction (NCT06154395) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction
China90 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microvascular obstruction (MVO) assessed by cardiac magnetic resonance imaging (CMR)
Timeframe: Three days after percutaneous coronary intervention (PCI)
. 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;