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Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)

30. dubna 2026 aktualizováno: Yu Bo, Harbin Medical University

Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)

This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Eligible patients must have residual DS < 70% at the culprit lesion assessed by QCA, with optional thrombus aspiration, and TIMI flow of grade 3. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The planned enrollment period is 36 months, and all patients will be followed up for at least 12 months after randomization, with continued follow-up until the end of the study. The primary outcome is the first occurrence of TLF after randomization, defined as the composite of cardiovascular death, target vessel myocardial infarction, ischemia-driven target lesion revascularization. The study aims to verify whether guideline-recommended standard medical therapy is non-inferior to DES implantation combined with guideline-recommended standard medical therapy in AMI patients with non-severe coronary artery stenosis.

A total of 120 participants (60 in the experimental group and 60 in the control group) enrolled at the Second Affiliated Hospital of Harbin Medical University were included in the functional substudy. Using Abbott Pressure Wire™X pressure wire test functional indicators, and explore the incidence of coronary microvascular dysfunction (CMD) as assessed by the index of microcirculatory resistance (IMR) in two groups, and its impact on the rate of the composite endpoint of all-cause death and heart failure readmission occurring for the first time within 12 months.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

2000

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Jingbo Hou, Ph.D.
  • Telefonní číslo: 13303609625
  • E-mail: jingbohou@163.com

Studijní záloha kontaktů

Studijní místa

  • Čína
      • Beijing, Čína
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Kontakt:
          • Lei Song
      • Beijing, Čína
        • Beijing Luhe Hospital Affiliated to Capital Medical University
        • Kontakt:
          • Guangyao Zhai
      • Cangzhou, Čína
        • Cangzhou Central Hospital
        • Kontakt:
          • Jun Zhang
      • Chengde, Čína
        • Chengde Medical College Affiliated Hospital
        • Kontakt:
          • Ying Zhang
      • Chengdu, Čína
        • Sichuan Provincial People's Hospital
      • Dalian, Čína
        • The Second Affiliated Hospital of Dalian Medical University
        • Kontakt:
          • Xin Zhao
      • Dalian, Čína
        • The First Affiliated Hospital of Dalian Medical University
      • Dalian, Čína
        • The Central Hospital Affiliated to Dalian University of Technology
        • Kontakt:
          • Xiaoqun Zheng
      • Daqing, Čína
        • Daqing Oilfield General Hospital
        • Kontakt:
          • Zhiqi Sun
      • Harbin, Čína
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Hunan, Čína
        • The Third Xiangya Hospital of Central South University
        • Kontakt:
          • Yu Cao
      • Jiamusi, Čína
        • Central Hospital of Jiamusi City
      • Jiamusi, Čína
        • The First Affiliated Hospital of Jiamusi University
        • Kontakt:
          • Guangyuan Yang
      • Jilin, Čína
        • China-Japan Union Hospital of Jilin University
        • Kontakt:
          • Yuquan He
      • Jilin, Čína
        • The First Hospital of Jilin University
        • Kontakt:
          • Qian Tong
      • Jilin, Čína
        • Jilin Central Hospital
        • Kontakt:
          • Yijun Shang
      • Jinan, Čína
        • Shandong Provincial Hospital
      • Jining, Čína
        • The Affiliated Hospital of Jining Medical University
        • Kontakt:
          • Lijun Gan
      • Lanzhou, Čína
        • Lanzhou University First Hospital
      • Linyi, Čína
        • Linyi People's Hospital
        • Kontakt:
          • Yanjin Wei
      • Mudanjiang, Čína
        • Mudanjiang Cardiovascular Hospital
        • Kontakt:
          • Kai Liu
      • Nanyang, Čína
        • The First Affiliated Hospital of Nanyang Medical College
        • Kontakt:
          • Ou Zhang
      • Qingdao, Čína
        • The Affiliated Hospital of Qingdao University
        • Kontakt:
          • Zhexun Lian
      • Qiqihar, Čína
        • Qiqihar First Hospital
        • Kontakt:
          • Jinhui Zhang
      • Qiqihar, Čína
        • The Second Affiliated Hospital of Qiqihar Medical University
      • Qiqihar, Čína
        • The Third Affiliated Hospital of Qiqihar Medical University
      • Shenyang, Čína
        • Shengjing Hospital Of China Medical University
        • Kontakt:
          • Zhijun Sun
      • Shenyang, Čína
        • Liaoning Provincial People's Hospital
        • Kontakt:
          • Bo Luan
      • Shenyang, Čína
        • The fourth Affiliated Hospital of China Medical University
        • Kontakt:
          • Yuanzhe Jin
      • Shijia Zhuang, Čína
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Čína
        • Hebei Provincial People's Hospital
        • Kontakt:
          • Yi Dang
      • Suihua, Čína
        • Suihua First Hospital
        • Kontakt:
          • Qiuye Yang
      • Taiyuan, Čína
        • General Hospital of Taiyuan Iron and Steel (Group) Co.
      • Taiyuan, Čína
        • Shanxi Provincial Cardiovascular Hospital
        • Kontakt:
          • Zhulin Zhang
      • Tianjin, Čína
        • General Hospital of Tianjin Medical University
        • Kontakt:
          • Qing Yang
      • Tianjin, Čína
        • Tianjin Chest Hospital
        • Kontakt:
          • Chunjie Li
      • Tianjin, Čína
        • TEDA International Cardiovascular Hospital
        • Kontakt:
          • Wenhua Lin
      • Wenzhou, Čína
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Kontakt:
          • Xueqiang Guan
      • Wuhan, Čína
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
          • Xiang Cheng
      • Wuhan, Čína
        • Wuhan Asia Heart Hospital
        • Kontakt:
          • Hua Yan
      • Xi'an, Čína
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xinjiang, Čína
        • The first affiliated hospital of Xinjiang medical university
        • Kontakt:
          • Xiang Ma
      • Xinjiang, Čína
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Yantai, Čína
        • Yantai Yuhuangding Hospital
      • Zhengzhou, Čína
        • The first affiliated hospital of Zhengzhou university
        • Kontakt:
          • Jinying Zhang
      • Zhengzhou, Čína
        • Fuwai Huazhong Cardiovascular Hospital
      • Zunyi, Čína
        • Zunyi Medical University Affiliated Hospital
        • Kontakt:
          • Ranzun Zhao

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Male or female patients aged ≥18 years and ≤75 years;
  2. Diagnosis of type 1 AMI, including STEMI (onset <24 hours or 7-14 days) or NSTEMI;
  3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) <70% at the culprit lesion (QCA);
  4. Reference diameter of the culprit lesion >2.5 mm and ≤4.0 mm;
  5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

1.Clinical exclusion criteria:

  1. Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF < 30%;
  2. Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
  3. Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
  4. Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
  5. Contraindication to contrast;
  6. Severe renal dysfunction [defined as eGFR ≤30 ml/min/1.73m² or Scr ≥2.0 mg/dL] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment);
  7. Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST >3× upper limit of normal (ULN);
  8. Previous history of CABG or PCI for the culprit lesion;
  9. Patients with other concurrent severe diseases and an expected life expectancy of <1 year;
  10. Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
  11. Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.

2.Imaging exclusion criteria:

  1. Non-culprit lesion with DS ≥70% or planned revascularization;
  2. Left main coronary artery lesion with DS ≥50%;
  3. Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
  4. Long lesion (planned stent length >60 mm);
  5. Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
  6. Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).

3.Functional sub study:

  1. Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
  2. Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
  3. Patients with bronchial asthma.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Lék: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Aktivní komparátor: DES implantation plus guideline-recommended standard medical therapy
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Postup: DES implantation plus guideline-recommended standard medical therapy
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Target Lesion Failure(TLF)
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
TLF is defined as a composite endpoint consisting of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization.
From randomization to the end of the study, median follow-up duration is 30 months.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
All-cause death
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Cardiovascular death
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Myocardial infarction (MI)
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel myocardial infarction
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Coronary Revascularization
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel revascularization
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target lesion revascularization
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Ischemia-driven target lesion revascularization
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Stroke
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for unstable angina pectoris
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for heart failure
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization.
From randomization to the end of the study, median follow-up duration is 30 months.
Seattle Angina Questionnaire(SAQ)score
Časové okno: From 24 hours after surgery to discharge and the 12th month after discharge
From 24 hours after surgery to discharge and the 12th month after discharge

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Definite or probable in-stent thrombosis
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Contrast-induced acute kidney injury(CI-AKI)
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Procedure-related myocardial infarction
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Bleeding Academic Research Consortium(BARC)type 3 and type 5 bleeding
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Microcirculation resistance index(IMR)to assess the incidence of coronary microvascular dysfunction (CMD)
Časové okno: From randomization to the end of the study, median follow-up duration is 30 months.
Exploratory endpoint:Functional sub research
From randomization to the end of the study, median follow-up duration is 30 months.
The first occurrence of all-cause death and readmission due to heart failure within 12 months.
Časové okno: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Harbin Medical University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bo Yu, Ph.D., The Second Affiliated Hospital of Harbin Medical University
  • Vrchní vyšetřovatel: Jingbo Hou, Ph.D., The Second Affiliated Hospital of Harbin Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. dubna 2026

Primární dokončení (Odhadovaný)

1. dubna 2029

Dokončení studie (Odhadovaný)

1. prosince 2030

Termíny zápisu do studia

První předloženo

21. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

30. dubna 2026

První zveřejněno (Aktuální)

5. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KY2026-042

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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