Comparison of Clinical Outcomes of Intravascular Ultrasound (IVUS) -Guided and Angiography-Guided Primary Percutaneous Intervention (PCI) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI)

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 countryJune 18, 2021

ConditionsST Elevation Myocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ST Elevation Myocardial Infarction
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations: 1
Status: Available
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

June 18, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical Inclusion (CI) Criteria: CI. Age \> 18 years C
•Onset of STEMI \> 30 minutes, but \< 12 hours C
•ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C
•Willing and able to provide informed consent
•Angiographic Inclusion (AI) Criteria (visual estimate) AI
•Having at least one infarct-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 AI
•No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Exclusion Criteria

•Clinical Exclusion (CE) Criteria CE
•Contraindicating to any concomitant study medications CE
•Having cardiogenic shock with hemodynamic instability CE
•A history of bleeding diathesis or known coagulopathy CE
•A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count \< 100,000 /mm3 or Hb \< 10 g/dL CE
•Planned surgery which may cause discontinuation of ADP-receptor antagonist CE
•Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE
•Repeated MI within 7 days of hospitalization for acute MI
•Angiographic Exclusion (AE) Criteria (visual estimate) AE
•Bifurcated lesion unable to identify the culprit lesion AE