Comparison of Clinical Outcomes of IVUS -Guided and Angiography-guided PCI in Patients With Acute STEMI

Last updated: January 21, 2024
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Planned

Phase

N/A

Condition

Heart Defect

Coronary Artery Disease

Congestive Heart Failure

Treatment

Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)

Clinical Study ID

NCT04929158
clinical 2020-401
  • Ages > 18
  • All Genders

Study Summary

To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI

Eligibility Criteria

Inclusion

Inclusion Criteria:

-Clinical Inclusion (CI) Criteria: CI. Age > 18 years C2. Onset of STEMI > 30 minutes, but < 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newlydeveloped LBBB on ECG C4. Willing and able to provide informed consent

  • Angiographic Inclusion (AI) Criteria (visual estimate) AI1. Having at least oneinfarct-related coronary artery of which
  • the Culprit lesion is suitable for stenting
  • the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm
  • the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing AI2. Noexcessive tortuosity and calcification in the culprit lesion segment that allowingstent implantation

Exclusion

Exclusion Criteria:

  • Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant studymedications CE2. Having cardiogenic shock with hemodynamic instability CE3. A historyof bleeding diathesis or known coagulopathy CE4. A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history ofintracranial tumor, aneurysm or arteriovenous malformations; or a history of activepeptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; orplanned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or Hb < 10 g/dL CE5. Planned surgery which may cause discontinuation of ADP-receptorantagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancyto less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI
  • Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unableto identify the culprit lesion AE2. The culprit lesion is located in the left mainartery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previousstent implantation in the culprit lesion segment or STEMI caused by stent thrombosisAE5. Likely CABG procedure within 30 days

Study Design

Treatment Group(s): 1
Primary Treatment: Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
Phase:
Study Start date:
Estimated Completion Date:

Study Description

This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.

Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.

Each center recruiting number does not exceed 40% of the total plan recruitment.

Connect with a study center

  • 2nd Affiliated Hospital, School of Medicine at Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Planned

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