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

30. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

2000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Arzneimittel: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
Aktiver Komparator: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Target Lesion Failure(TLF)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-cause death
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Definite or probable in-stent thrombosis
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Harbin Medical University

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. April 2026

Primärer Abschluss (Geschätzt)

1. April 2029

Studienabschluss (Geschätzt)

1. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

21. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

5. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KY2026-042

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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