Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126944
Enrollment
Unknown
Registered
2026-06-20
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST-Segment Elevation Myocardial Infarction

Interventions

Experimental group:primary Percutaneous Coronary Intervention + Recombinant Streptokinase for Injection (300,000 IU in 5 mL 5% glucose, administered intracoronary, with additional doses allowed as nee
Control group:primary Percutaneous Coronary Intervention

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for acute ST-segment elevation myocardial infarction. 2. The symptoms of STEMI occurred within 12 hours. 3. TIMI thrombus grade >= 2. 4. Age 18 - 75 years old (inclusive), gender not restricted. 5. The research participants voluntarily participated in this study. The participants themselves or their legal representatives signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating females. 2.Patients with severe cardiovascular diseases, including cardiogenic shock, cardiac rupture, and those with suspected aortic dissection, coronary artery dissection, aneurysm or other acute aortic syndromes. 3.Patients with coronary artery disease unsuitable for revascularization. 4.Patients with previously confirmed severe cardiac diseases. 5.Patients receiving cardiopulmonary resuscitation or ventricular fibrillation unconvertible after 3 times of electrical cardioversion. 6.Patients with continuous oral anticoagulant therapy for no less than 3 months. 7.Patients with high bleeding risk or other conditions unsuitable for thrombolytic therapy. 8.Patients with body weight less than 40 kg or more than 200 kg. 9.Patients allergic to recombinant streptokinase or contrast agents. 10.Patients complicated with other systemic diseases, including those with expected survival time less than 1 year due to other illnesses, severe hepatic and renal dysfunction, hematological diseases, acute pancreatitis, diabetes combined with retinopathy, disturbance of consciousness, malignant tumors, etc. 11.Patients deemed ineligible for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Post-procedure immediate angiography-based index of microcirculatory resistance (caIMR);

Secondary

MeasureTime frame
Corrected TIMI Frame Count (CTFC) immediately after procedure;1-year post-procedure Major Adverse Cardiovascular Events incidence;Length of hospital stay;Proportion of study participants with ST-segment resolution >50% and >70% on ECG at 1 hour after the procedure;Myocardial infarct size, myocardial salvage index (MSI), left ventricular ejection fraction (LVEF), microvascular obstruction, and intramyocardial hemorrhage;Post-procedure immediate TIMI flow grade;Post-procedure immediate angiography-based fractional flow reserve (caFFR);

Countries

China

Contacts

Public ContactLu Yuan

The Affiliated Hospital of Xuzhou Medical University

Luyuan329@163.com+86 516 8580 5192

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026