Status:
UNKNOWN
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Ningbo No. 1 Hospital
First Affiliated Hospital of Wenzhou Medical University
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.
Detailed Description
Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized...
Eligibility Criteria
Inclusion
- Clinical inclusion criteria:
- Age \> 18 years
- Onset of STEMI \> 30 minutes, but \< 12 hours
- ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
- Willing and able to provide informed consent
- Angiographic inclusion criteria:
- Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
- No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Exclusion
- Clinical exclusion criteria:
- Contraindicating to any concomitant study medications
- Having cardiogenic shock with hemodynamic instability
- A history of bleeding diathesis or known coagulopathy
- 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
- Planned surgery which may cause discontinuation of ADP-receptor antagonist
- Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
- Repeated MI within 7 days of hospitalization for acute MI
- Anigographic
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04063345
Start Date
October 1 2021
End Date
October 1 2023
Last Update
January 29 2021
Active Locations (1)
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1
Second affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009