Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (RE… (NCT07601997) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study)
China20 participantsStarted 2026-05-30
Plain-language summary
The purpose of this clinical trial is to preliminarily evaluate the safety and feasibility of the transcatheter injectable protein alginate-based hydrogel developed and manufactured by Myomed Technology (Shaoxing) Co., Ltd. in alleviating reperfusion injury in acute STEMI. This is a randomized controlled trial with a blank control group (conventional PCI treatment). A total of 20 patients will be enrolled in a 1:1 ratio into the test group and the control group.
Who can participate
Age range
18 Years – 80 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.
. Ischemic symptoms (e.g., chest pain, precordial discomfort) persist for \>30 minutes, and electrocardiographic findings meet the following criteria: ST-segment (J-point) elevation ≥1.0 mm (i.e., amplitude 0.1 mV) in all conventional leads except leads V2 and V3. For leads V2 and V3, the ST-segment elevation criteria are: ≥2.5 mm in males \<40 years old, ≥2.0 mm in males ≥40 years old, and ≥1.5 mm in females of all ages;
. The time interval from the onset of ischemic symptoms to the first PCI balloon dilation is ≤12 hours;
. Admission coronary angiography shows that the left anterior descending artery (LAD) has a TIMI flow grade of 0 (complete occlusion), and the TIMI flow grade reaches 3 after stent implantation;
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.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it even be realistic to consider it given how quickly decisions need to be made after a STEMI?
2Since this study is listed as Phase NA and is primarily measuring safety and feasibility rather than whether the hydrogel treatment actually improves outcomes, what does that mean for what's already known about its risks and benefits compared to my current standard of care?
3The trial is tracking Major Adverse Events within 30 days after the procedure — based on what you know about this type of injectable hydrogel approach, what kinds of complications are they specifically trying to rule out, and how serious could those be?
4The study measures something called the Myocardial Salvage Index — can you explain what that means for my heart and whether that's the kind of outcome that would actually matter to my long-term recovery?
5Given that this trial involves an additional transcatheter procedure on top of the reperfusion treatment I'd already be receiving, is there a realistic concern that participating could add procedural risk at an already critical moment, and would waiting for standard treatment first be the safer path?
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
Incidence of Major Adverse Events (MAEs) within 30 days after surgery
Timeframe: within 30 days
2
Myocardial Salvage Index (MSI)
Timeframe: 7 days, 3 months and 6 months post-procedure.
. Able to understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form personally or via a legal representative, and be willing to complete the follow-up in accordance with the protocol requirements.
Exclusion criteria
. Complicated with cardiogenic shock or cardiac arrest; or complicated with acute myocardial infarction mechanical complications requiring surgical or interventional intervention (e.g., ventricular septal perforation, papillary muscle rupture, free wall rupture), or complicated with giant left ventricular aneurysm;
. Previously diagnosed with hypertrophic cardiomyopathy, hemodynamically significant congenital heart disease, severe valvular heart disease, chronic cor pulmonale, chronic heart failure, or with a history of cardiac tamponade, pericarditis, or myocarditis;
. History of previous myocardial infarction, coronary intervention (PCI), or coronary artery bypass grafting (CABG);
. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months;
. Heart failure severity at admission reaches Killip classification Grade III or above;
. Complicated with malignant arrhythmia, complete atrioventricular block, or new-onset complete left bundle branch block (LBBB);