STEMI - ST Elevation Myocardial InfarctionNCT07601997
Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study)
A study testing Injectable protein alginate-based hydrogel and No additional intervention in people with STEMI - ST Elevation Myocardial Infarction, run by Myomed Technology (Shaoxing) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Injectable protein alginate-based hydrogel and No additional intervention
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years;
- Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;
- 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;
- 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.
Who cannot join
- 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);
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- Diagnosed or suspected aortic dissection;
- Diabetes mellitus with severe complications;
- Complicated with atrial fibrillation and receiving only warfarin treatment, or with a high bleeding risk;
- Received thrombolytic therapy prior to PCI;
- Diameter of the infarct-related artery < 2 mm or abundant coronary collateral circulation in the risk area;
- Coronary angiography indicates diffuse vascular lesions or severe calcification that may affect the absorption of protein alginate-based hydrogel;
- Severe complications (e.g., coronary artery rupture, perforation, or stent dislodgement) occurring during PCI;
- Received coronary bioresorbable stent implantation;
- Complicated with severe acute infection requiring systemic treatment;
- Currently diagnosed with malignant tumor or receiving malignant tumor treatment;
- Severe autoimmune disease requiring therapeutic intervention;
- History of severe anemia (hemoglobin < 60 g/L) or thrombocytopenia (platelet count < 100×10⁹/L);
- Known renal insufficiency (including estimated creatinine clearance < 30 ml/min/1.73 m², or receiving treatment for severe renal insufficiency);
- Alanine aminotransferase (ALT) level exceeding 3 times the upper limit of normal, with the investigator judging clinically significant liver dysfunction;
- Known allergy to the study product or any radiocontrast agent;
- Contraindications to cardiovascular magnetic resonance (CMR) examination (e.g., implanted cardiac pacemaker, implantable cardioverter-defibrillator, nerve stimulator, cerebral aneurysm clip, cochlear implant, or claustrophobia);
- Cognitive dysfunction, dementia, or severe mental illness;
- Currently participating in other clinical trials and have not yet reached the primary endpoint;
- Expected survival period < 1 year due to comorbidities;
- Pregnant or lactating women, or fertile subjects who do not take effective medical contraceptive measures during the study period;
- Other factors that the investigator deems may have a significant impact on result judgment or the safety and efficacy of the subjects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi
Clinical Research Associate, 021-0575-88605679, Welly_wwx@126.com
Fei Li
About this study
Official title: Clinical Application Study on the Safety and Feasibility of Transcatheter Injectable Protein Alginate-based Hydrogel for Alleviating Reperfusion Injury in Acute STEMI
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.
- Being tested
- Injectable protein alginate-based hydrogel, No additional intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable protein alginate-based hydrogelDevice
Experimental group: PCI combined with the locally injectable inert material
No additional interventionOther
Conventional PCI procedure
| Study group | Role | What they receive |
|---|---|---|
| Hydrogel Group | Experimental | Not described Receives: Device: Injectable protein alginate-based hydrogel |
| Blank Control Group | Other | Not described Receives: Other: No additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Events (MAEs) within 30 days after surgery
Defined as all-cause death, stroke, target vessel myocardial infarction, new-onset severe heart failure, cardiac arrest, cardiogenic shock, sustained ventricular arrhythmia, target vessel revascularization, and any device-related complications.
Measured: within 30 days
Myocardial Salvage Index (MSI)
Score range: 0 to 1.0. Higher MSI values indicate better myocardial salvage and superior clinical outcome; lower values indicate smaller salvaged myocardial area and worse outcome.
Measured: 7 days, 3 months and 6 months post-procedure.
Secondary outcomes (21)
Incidence of serious adverse events and device-related adverse events
Measured: 7 days, 30 days, 3 months, and 6 months post-procedure
Immediate surgical success
Defined as successful delivery of the investigational product to the predefined target site via catheter, satisfactory immediate angiographic results, uneventful catheter withdrawal, and absence of serious adverse events throughout the procedure.
Measured: Immediately after the procedure
AUC of CK-MB and hs-cTnI
Measured: baseline, 1 day, 3 days and 7 days post-procedure
Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels
Measured: 1 day, 3 days and 7days post-procedure
Concentrations of BNP/NT-proBNP and hsCRP
Measured: baseline, 1 day, 3 days, 7days and 6 months post-procedure
To assess changes in the grade of Segmental Wall Motion Abnormality (SWMA) in target segments based on the ASE 17-segment model, as well as the reduction rate of segments with wall motion abnormalities.
CMR and TTE
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in mean Segmental Wall Thickening Rate (SWTR) of target segments.
CMR
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in left ventricular global longitudinal strain (LVGLS).
CMR and TTE
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial perfusion status
CMR first pass perfusion imaging (PFI)
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial extracellular volume (ECV).
CMR
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular end-diastolic volume (LVEDV)
Detection method: cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE)
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular end-systolic volume (LVESV)
Detection method: cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE)
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular ejection fraction (LVEF)
Detection method: cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE)
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in Transmural Myocardial Infarction (TMI) grade
CMR
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in intramyocardial hemorrhage (IMH) area.
CMR
Measured: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial infarct size
CMR
Measured: 7 days, 3 months and 6 months post-procedure
Changes in NYHA classification
Measured: 7 days, 30 days, 3 months and 6 months post-procedure
Cardiovascular mortality
Measured: 6 months post-procedure
Incidence of recurrent myocardial infarction
Measured: 6 months post-procedure
Heart failure readmission rate
Measured: 6 months post-procedure
All-cause mortality
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myomed Technology (Shaoxing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601997
- Sponsor's protocol ID
- MR-002-CARP-01
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Study on the Safety and Feasibility of Transcatheter Injectable Protein Alginate-based Hydrogel for Alleviating Reperfusion Injury in Acute STEMI
- ClinicalTrials.gov ID
- NCT07601997
- Acronym / sponsor ID
- MR-002-CARP-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Myomed Technology (Shaoxing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogel Group | Experimental | Device: Injectable protein alginate-based hydrogel |
| Blank Control Group | Other | Other: No additional intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 80 years;
- Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;
- 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;
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable protein alginate-based hydrogelExperimental group: PCI combined with the locally injectable inert material | Device | Hydrogel Group |
| No additional interventionConventional PCI procedure | Other | Blank Control Group |
Primary outcome
Incidence of Major Adverse Events (MAEs) within 30 days after surgery
Time frame: within 30 days
Defined as all-cause death, stroke, target vessel myocardial infarction, new-onset severe heart failure, cardiac arrest, cardiogenic shock, sustained ventricular arrhythmia, target vessel revascularization, and any device-related complications.
Myocardial Salvage Index (MSI)
Time frame: 7 days, 3 months and 6 months post-procedure.
Score range: 0 to 1.0. Higher MSI values indicate better myocardial salvage and superior clinical outcome; lower values indicate smaller salvaged myocardial area and worse outcome.
21 secondary outcomes
Incidence of serious adverse events and device-related adverse events
Time frame: 7 days, 30 days, 3 months, and 6 months post-procedure
Immediate surgical success
Time frame: Immediately after the procedure
AUC of CK-MB and hs-cTnI
Time frame: baseline, 1 day, 3 days and 7 days post-procedure
Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels
Time frame: 1 day, 3 days and 7days post-procedure
Concentrations of BNP/NT-proBNP and hsCRP
Time frame: baseline, 1 day, 3 days, 7days and 6 months post-procedure
To assess changes in the grade of Segmental Wall Motion Abnormality (SWMA) in target segments based on the ASE 17-segment model, as well as the reduction rate of segments with wall motion abnormalities.
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in mean Segmental Wall Thickening Rate (SWTR) of target segments.
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in left ventricular global longitudinal strain (LVGLS).
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial perfusion status
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial extracellular volume (ECV).
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular end-diastolic volume (LVEDV)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular end-systolic volume (LVESV)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular ejection fraction (LVEF)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in Transmural Myocardial Infarction (TMI) grade
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in intramyocardial hemorrhage (IMH) area.
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial infarct size
Time frame: 7 days, 3 months and 6 months post-procedure
Changes in NYHA classification
Time frame: 7 days, 30 days, 3 months and 6 months post-procedure
Cardiovascular mortality
Time frame: 6 months post-procedure
Incidence of recurrent myocardial infarction
Time frame: 6 months post-procedure
Heart failure readmission rate
Time frame: 6 months post-procedure
All-cause mortality
Time frame: 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable protein alginate-based hydrogel and No additional intervention in people with STEMI - ST Elevation Myocardial Infarction, run by Myomed Technology (Shaoxing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Medical Director (86-17621666472, contact@myomedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Events (MAEs) within 30 days after surgery (time frame: within 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.