ST Elevation Myocardial Infarction (STEMI)Phase 4IMPROVE-STEMINCT07875179
IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI
A Phase 4 study testing Recombinant Streptokinase in people with ST Elevation Myocardial Infarction (STEMI), run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is a multicenter, prospective, pragmatic, randomized controlled trial (IMPROVE-STEMI) aiming to evaluate the efficacy and safety of intracoronary low-dose recombinant streptokinase combined with primary percutaneous coronary intervention (pPCI) in patients with acute ST-segment elevation myocardial infarction… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ST Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Recombinant Streptokinase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2026to 28 Sep 2028
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) according to the guidelines.
- Onset of STEMI symptoms within 12 hours.
- TIMI thrombus grade ≥ 2.
- Age 18 to 75 years, inclusive, gender (male or female).
- Written informed consent obtained from the patient or their legal representative.
Who cannot join
- Pregnant or breastfeeding women.
- Severe cardiovascular diseases, including cardiogenic shock, cardiac rupture, or acute aortic syndrome (e.g., aortic dissection, coronary artery dissection, or aneurysm) that cannot be excluded.
- Known coronary artery disease unsuitable for revascularization.
- Previously known severe heart disease.
- Patients with ventricular fibrillation requiring cardiopulmonary resuscitation or refractory to 3 electrical defibrillation attempts.
- Continuous oral anticoagulant use for ≥ 3 months.
Show all 11Show fewer
- High risk of bleeding or other contraindications to thrombolytic therapy.
- Body weight < 40 kg or > 200 kg.
- Allergy to recombinant streptokinase or contrast agents.
- Other systemic diseases, including life expectancy < 1 year due to other diseases, severe liver or kidney dysfunction, hematological diseases, acute pancreatitis, diabetic retinopathy, consciousness disorders, or malignant tumors.
- Any condition that the investigator considers unsuitable for participation in this study.
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
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Yuan Lu, M.D., +86 85805192, drluyuan329@163.com
About this study
Official title: Impact of Intra-procedural pPCI Combined With Low-dose Recombinant Streptokinase on Coronary MicroVascular Dysfunction and Events in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Multicenter, Prospective, Pragmatic, Randomized Controlled Trial Protocol
This is a multicenter, prospective, pragmatic, randomized controlled trial (IMPROVE-STEMI) aiming to evaluate the efficacy and safety of intracoronary low-dose recombinant streptokinase combined with primary percutaneous coronary intervention (pPCI) in patients with acute ST-segment elevation myocardial infarction (STEMI).
A total of 3,300 patients will be enrolled, consisting of a core randomized study (300 patients, 1:1 ratio to pPCI + recombinant streptokinase vs. pPCI alone) and an extended observational study (3,000 patients receiving pPCI + recombinant streptokinase). The primary outcome measure is the coronary angiography-derived index of microcirculatory resistance (caIMR) immediately after the procedure. Secondary outcomes include the incidence of major adverse cardiovascular events (MACE) at 1 year, TIMI flow grade, corrected TIMI frame count (CTFC), and myocardial salvage index.
The study duration is 24 months after the first patient enrollment, with follow-up visits scheduled at Day 5, Week 4, Week 12, Week 24, and Week 52.
Read the detailed description
Background:
Acute ST-segment elevation myocardial infarction (STEMI) is a critical condition caused by acute thrombotic occlusion of coronary arteries. Although primary percutaneous coronary intervention (pPCI) is the standard treatment, high thrombus burden often leads to slow flow or no-reflow phenomenon, affecting patient prognosis. Intracoronary thrombolysis has emerged as an adjunctive strategy to improve microvascular perfusion. Recombinant streptokinase, a genetically engineered thrombolytic agent with reduced antigenicity, has shown potential in improving myocardial reperfusion. This study aims to systematically evaluate the efficacy and safety of pPCI combined with intracoronary low-dose recombinant streptokinase in STEMI patients, and to provide high-level evidence for clinical translation.
Study Design:
This study consists of two parts:
Core Study: A multicenter, prospective, open-label, pragmatic, randomized controlled trial. A total of 300 patients will be randomized 1:1 to the experimental group (pPCI + intracoronary recombinant streptokinase, n=150) or the control group (pPCI alone, n=150).
Extended Study: A multicenter, prospective, open-label, observational study. A total of 3,000 patients will be enrolled to receive pPCI + intracoronary recombinant streptokinase.
Intervention:
In the experimental group, patients will receive an intracoronary injection of 300,000 IU recombinant streptokinase dissolved in 5% glucose 5mL, administered distal to, within, and proximal to the thrombus via a microcatheter or perforated balloon after guidewire crossing. The control group will receive standard pPCI only. Concomitant use of other thrombolytic agents (e.g., urokinase, alteplase, reteplase, tenecteplase, recombinant human prourokinase) is prohibited during the observation period.
Outcomes:
The primary outcome is the coronary angiography-derived index of microcirculatory resistance (caIMR) immediately after PCI. Secondary outcomes include:
Incidence of MACE (all-cause death, recurrent myocardial infarction, target vessel revascularization, heart failure rehospitalization, and stroke) at 1 year.
TIMI flow grade and corrected TIMI frame count (CTFC) immediately after PCI.
Coronary angiography-derived fractional flow reserve (caFFR).
ST-segment resolution >50% and >70% at 1 hour post-PCI.
Myocardial infarct size, myocardial salvage index (MSI), left ventricular ejection fraction (LVEF), microvascular obstruction, and intramyocardial hemorrhage (assessed by cardiac MRI at Day 5 ± 2 days).
Length of hospital stay.
Sample Size:
For the core study, assuming a mean caIMR of 28.19 ± 7.26 in the experimental group and 33.56 ± 8.47 in the control group, with a 1:1 ratio, α=0.05 (two-sided), and 90% power, 94 patients are required. Considering a 20% dropout rate, 118 patients are needed. To account for center effects and improve subgroup analysis power, the final sample size is set at 300 patients (150 per group). For the extended study, a single-arm target value method is used, with a planned enrollment of 3,000 patients to describe caIMR distribution and accumulate safety data in various subgroups.
Follow-up:
The observation period is divided into screening/baseline (Day -1 to 0), treatment (Day 0), and follow-up (Day 5 ± 2, Week 4 ± 7, Week 12 ± 7, Week 24 ± 7, and Week 52 ± 7). The primary analysis will use the Full Analysis Set (FAS) and Safety Set (SS). Statistical analysis will be performed using SAS 9.4.
Safety:
Safety endpoints include major and minor bleeding events (TIMI criteria) within 7 days, vital signs, blood routine, liver and kidney function, and the incidence of adverse events. The study has been approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (Approval Number: XYFY2026-KL268-01).
- Being tested
- Recombinant Streptokinase
- Keywords
- STEMI, Primary PCI, Recombinant Streptokinase, Intracoronary Thrombolysis, Coronary Microvascular Dysfunction, caIMR, MACE, Pragmatic Randomized Controlled Trial
- 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.
Recombinant StreptokinaseDrug
Intracoronary administration of 300,000 IU recombinant streptokinase dissolved in 5% glucose 5mL, injected distal to, within, and proximal to the thrombus via a microcatheter or perforated balloon after guidewire crossing.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: pPCI + r-SK | Experimental | Standard pPCI procedure combined with intracoronary low-dose recombinant streptokinase (300,000 IU dissolved in 5% glucose 5mL). Receives: Drug: Recombinant Streptokinase |
| Control: pPCI only | No intervention | Standard pPCI procedure only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Angiography-derived Index of Microcirculatory Resistance (caIMR)
Microcirculatory resistance index calculated from coronary angiography images immediately after PCI.
Measured: Immediately after PCI
Secondary outcomes (10)
Incidence of Major Adverse Cardiovascular Events (MACE)
A composite of all-cause death, recurrent myocardial infarction, unplanned ischemia-driven target vessel revascularization, heart failure rehospitalization, and new-onset stroke.
Measured: 1 year after PCI
Corrected TIMI Frame Count (CTFC)
Measured: Immediately after PCI
Coronary Angiography-derived Fractional Flow Reserve (caFFR)
Measured: Immediately after PCI
Proportion of patients with ST-segment resolution >50% and >70%
Measured: 1 hour after PCI
Myocardial Infarct Size
Assessed by cardiac magnetic resonance (CMR) imaging.
Measured: Day 5 ± 2 days after PCI
Myocardial Salvage Index
Assessed by cardiac magnetic resonance (CMR) imaging.
Measured: Day 5 ± 2 days after PCI
Left Ventricular Ejection Fraction
Assessed by cardiac magnetic resonance (CMR) imaging.
Measured: Day 5 ± 2 days after PCI
Microvascular Obstruction
Assessed by cardiac magnetic resonance (CMR) imaging.
Measured: Day 5 ± 2 days after PCI
Intramyocardial Hemorrhage
Assessed by cardiac magnetic resonance (CMR) imaging.
Measured: Day 5 ± 2 days after PCI
Length of Hospital Stay
The total number of days the participant stayed in the hospital after the PCI procedure.
Measured: Up to 14 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completion28 Sep 2028 (estimated)
- Study completion28 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial Infarction (STEMI)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two parts. The core study is a multicenter, prospective, open-label, pragmatic, randomized controlled trial (RCT) with two parallel arms (1:1 ratio): the experimental group (pPCI + intracoronary recombinant streptokinase) and the control group (pPCI alone). The extended study is a multicenter, prospective, open-label, observational study, in which all enrolled patients receive pPCI + intracoronary recombinant streptokinase. A single center cannot participate in both parts simultaneously.
- Masking
- None (open label)
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China Association for Disaster & Emergency Rescue Medicine, Henan Singtier Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yuan Lu, M.D., Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875179
- Sponsor's protocol ID
- r-SK-pRCT-001
- Acronym
- IMPROVE-STEMI
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from this study are jointly owned by the sponsor and the investigational sites. Due to confidentiality agreements and the protection of participant privacy, individual participant data will not be shared with third parties.
Publications
Xiao Y, Fu X, Wang Y, Fan Y, Wu Y, Wang W, Zhang Q. Effects of different strategies on high thrombus burden in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization. Coron Artery Dis. 2019 Dec;30(8):555-563. doi: 10.1097/MCA.0000000000000743.
PubMed 30998610Rehan R, Virk S, Wong CCY, Passam F, Layland J, Keech A, Yong A, White HD, Fearon W, Ng M. Intracoronary thrombolysis in ST-elevation myocardial infarction: a systematic review and meta-analysis. Heart. 2024 Jul 10;110(15):988-996. doi: 10.1136/heartjnl-2024-324078.
PubMed 38925881
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intra-procedural pPCI Combined With Low-dose Recombinant Streptokinase on Coronary MicroVascular Dysfunction and Events in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Multicenter, Prospective, Pragmatic, Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07875179
- Acronym / sponsor ID
- IMPROVE-STEMI / r-SK-pRCT-001
- Keywords
- STEMI, Primary PCI, Recombinant Streptokinase, Intracoronary Thrombolysis, Coronary Microvascular Dysfunction, caIMR, MACE, Pragmatic Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- China Association for Disaster & Emergency Rescue Medicine, Henan Singtier Pharmaceutical Co., Ltd.
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 28 Sep 2028 (estimated)
- Study completion
- 28 Sep 2028 (estimated)
- First posted
- 15 Oct 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.
This is a multicenter, prospective, pragmatic, randomized controlled trial (IMPROVE-STEMI) aiming to evaluate the efficacy and safety of intracoronary low-dose recombinant streptokinase combined with primary percutaneous coronary intervention (pPCI) in patients with acute ST-segment elevation myocardial infarction (STEMI).
A total of 3,300 patients will be enrolled, consisting of a core randomized study (300 patients, 1:1 ratio to pPCI + recombinant streptokinase vs. pPCI alone) and an extended observational study (3,000 patients receiving pPCI + recombinant streptokinase). The primary outcome measure is the coronary angiography-derived index of microcirculatory resistance (caIMR) immediately after the procedure. Secondary outcomes include the incidence of major adverse cardiovascular events (MACE) at 1 year, TIMI flow grade, corrected TIMI frame count (CTFC), and myocardial salvage index.
The study duration is 24 months after the first patient enrollment, with follow-up visits scheduled at Day 5, Week 4, Week 12, Week 24, and Week 52.
Detailed description
Background:
Acute ST-segment elevation myocardial infarction (STEMI) is a critical condition caused by acute thrombotic occlusion of coronary arteries. Although primary percutaneous coronary intervention (pPCI) is the standard treatment, high thrombus burden often leads to slow flow or no-reflow phenomenon, affecting patient prognosis. Intracoronary thrombolysis has emerged as an adjunctive strategy to improve microvascular perfusion. Recombinant streptokinase, a genetically engineered thrombolytic agent with reduced antigenicity, has shown potential in improving myocardial reperfusion. This study aims to systematically evaluate the efficacy and safety of pPCI combined with intracoronary low-dose recombinant streptokinase in STEMI patients, and to provide high-level evidence for clinical translation.
Study Design:
This study consists of two parts:
Core Study: A multicenter, prospective, open-label, pragmatic, randomized controlled trial. A total of 300 patients will be randomized 1:1 to the experimental group (pPCI + intracoronary recombinant streptokinase, n=150) or the control group (pPCI alone, n=150).
Extended Study: A multicenter, prospective, open-label, observational study. A total of 3,000 patients will be enrolled to receive pPCI + intracoronary recombinant streptokinase.
Intervention:
In the experimental group, patients will receive an intracoronary injection of 300,000 IU recombinant streptokinase dissolved in 5% glucose 5mL, administered distal to, within, and proximal to the thrombus via a microcatheter or perforated balloon after guidewire crossing. The control group will receive standard pPCI only. Concomitant use of other thrombolytic agents (e.g., urokinase, alteplase, reteplase, tenecteplase, recombinant human prourokinase) is prohibited during the observation period.
Outcomes:
The primary outcome is the coronary angiography-derived index of microcirculatory resistance (caIMR) immediately after PCI. Secondary outcomes include:
Incidence of MACE (all-cause death, recurrent myocardial infarction, target vessel revascularization, heart failure rehospitalization, and stroke) at 1 year.
TIMI flow grade and corrected TIMI frame count (CTFC) immediately after PCI.
Coronary angiography-derived fractional flow reserve (caFFR).
ST-segment resolution >50% and >70% at 1 hour post-PCI.
Myocardial infarct size, myocardial salvage index (MSI), left ventricular ejection fraction (LVEF), microvascular obstruction, and intramyocardial hemorrhage (assessed by cardiac MRI at Day 5 ± 2 days).
Length of hospital stay.
Sample Size:
For the core study, assuming a mean caIMR of 28.19 ± 7.26 in the experimental group and 33.56 ± 8.47 in the control group, with a 1:1 ratio, α=0.05 (two-sided), and 90% power, 94 patients are required. Considering a 20% dropout rate, 118 patients are needed. To account for center effects and improve subgroup analysis power, the final sample size is set at 300 patients (150 per group). For the extended study, a single-arm target value method is used, with a planned enrollment of 3,000 patients to describe caIMR distribution and accumulate safety data in various subgroups.
Follow-up:
The observation period is divided into screening/baseline (Day -1 to 0), treatment (Day 0), and follow-up (Day 5 ± 2, Week 4 ± 7, Week 12 ± 7, Week 24 ± 7, and Week 52 ± 7). The primary analysis will use the Full Analysis Set (FAS) and Safety Set (SS). Statistical analysis will be performed using SAS 9.4.
Safety:
Safety endpoints include major and minor bleeding events (TIMI criteria) within 7 days, vital signs, blood routine, liver and kidney function, and the incidence of adverse events. The study has been approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (Approval Number: XYFY2026-KL268-01).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of two parts. The core study is a multicenter, prospective, open-label, pragmatic, randomized controlled trial (RCT) with two parallel arms (1:1 ratio): the experimental group (pPCI + intracoronary recombinant streptokinase) and the control group (pPCI alone). The extended study is a multicenter, prospective, open-label, observational study, in which all enrolled patients receive pPCI + intracoronary recombinant streptokinase. A single center cannot participate in both parts simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Experimental: pPCI + r-SK | Experimental | Drug: Recombinant StreptokinaseStandard pPCI procedure combined with intracoronary low-dose recombinant streptokinase (300,000 IU dissolved in 5% glucose 5mL). |
| Control: pPCI only | No intervention | –Standard pPCI procedure only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) according to the guidelines.
- Onset of STEMI symptoms within 12 hours.
- TIMI thrombus grade ≥ 2.
- Age 18 to 75 years, inclusive, gender (male or female).
- Written informed consent obtained from the patient or their legal representative.
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women.
- Severe cardiovascular diseases, including cardiogenic shock, cardiac rupture, or acute aortic syndrome (e.g., aortic dissection, coronary artery dissection, or aneurysm) that cannot be excluded.
- Known coronary artery disease unsuitable for revascularization.
- Previously known severe heart disease.
- Patients with ventricular fibrillation requiring cardiopulmonary resuscitation or refractory to 3 electrical defibrillation attempts.
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 |
|---|---|---|
| Recombinant StreptokinaseIntracoronary administration of 300,000 IU recombinant streptokinase dissolved in 5% glucose 5mL, injected distal to, within, and proximal to the thrombus via a microcatheter or perforated balloon after guidewire crossing. | Drug | Experimental: pPCI + r-SK |
Primary outcome
Coronary Angiography-derived Index of Microcirculatory Resistance (caIMR)
Time frame: Immediately after PCI
Microcirculatory resistance index calculated from coronary angiography images immediately after PCI.
10 secondary outcomes
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 1 year after PCI
Corrected TIMI Frame Count (CTFC)
Time frame: Immediately after PCI
Coronary Angiography-derived Fractional Flow Reserve (caFFR)
Time frame: Immediately after PCI
Proportion of patients with ST-segment resolution >50% and >70%
Time frame: 1 hour after PCI
Myocardial Infarct Size
Time frame: Day 5 ± 2 days after PCI
Myocardial Salvage Index
Time frame: Day 5 ± 2 days after PCI
Left Ventricular Ejection Fraction
Time frame: Day 5 ± 2 days after PCI
Microvascular Obstruction
Time frame: Day 5 ± 2 days after PCI
Intramyocardial Hemorrhage
Time frame: Day 5 ± 2 days after PCI
Length of Hospital Stay
Time frame: Up to 14 days after PCI
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 15 Oct 2026.
- Background: PubMed 30998610Xiao Y, Fu X, Wang Y, Fan Y, Wu Y, Wang W, Zhang Q. Effects of different strategies on high thrombus burden in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization. Coron Artery Dis. 2019 Dec;30(8):555-563. doi: 10.1097/MCA.0000000000000743.
- Results publication: PubMed 38925881Rehan R, Virk S, Wong CCY, Passam F, Layland J, Keech A, Yong A, White HD, Fearon W, Ng M. Intracoronary thrombolysis in ST-elevation myocardial infarction: a systematic review and meta-analysis. Heart. 2024 Jul 10;110(15):988-996. doi: 10.1136/heartjnl-2024-324078.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data from this study are jointly owned by the sponsor and the investigational sites. Due to confidentiality agreements and the protection of participant privacy, individual participant data will not be shared with third parties.
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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.
Yuan Lu, M.D. principal investigator
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Streptokinase in people with ST Elevation Myocardial Infarction (STEMI), run by The Affiliated Hospital of Xuzhou Medical University 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 5 inclusion and 11 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 15 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yuan Lu, M.D. (+86 85805192, drluyuan329@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Angiography-derived Index of Microcirculatory Resistance (caIMR) (time frame: Immediately after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07875179, which also lists 2 linked publications.
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 15 Oct 2026.