Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
NCT ID: NCT04063345
Last Updated: 2021-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2021-10-01
2023-10-01
Brief Summary
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Detailed Description
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There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IVUS-guided PCI
Percutaneous intervention under IVUS-guidance
IVUS-guided PCI
Performing intravascular ultrasound before or/and after percutaneous intervention
Angiography-guided PCI
Percutaneous intervention under angiograhy-guidance only
Angiography-guided PCI
Performing percutaneous intervention without intravascular ultrasound guidance
Interventions
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IVUS-guided PCI
Performing intravascular ultrasound before or/and after percutaneous intervention
Angiography-guided PCI
Performing percutaneous intervention without intravascular ultrasound guidance
Eligibility Criteria
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Inclusion Criteria
2. Onset of STEMI \> 30 minutes, but \< 12 hours
3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
4. Willing and able to provide informed consent
1. 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
2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Exclusion Criteria
2. Having cardiogenic shock with hemodynamic instability
3. A history of bleeding diathesis or known coagulopathy
4. 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
5. Planned surgery which may cause discontinuation of ADP-receptor antagonist
6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
7. Repeated MI within 7 days of hospitalization for acute MI
1. Bifurcated lesion unable to identify the culprit lesion
2. The culprit lesion is located in the left main artery
3. Diffusive lesions without distinguishable culprit lesion
4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
5. Likely CABG procedure within 30 days
6. Renal failure requiring or during dialysis
18 Years
ALL
No
Sponsors
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Ningbo No. 1 Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Shanghai Chest Hospital
OTHER
Taizhou Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jian-an Wang, MD, PhD
Role: STUDY_CHAIR
Second Affiliated Hospital of Zhejiang University, School of Medicine
Locations
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Second affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SAHZJU CT015
Identifier Type: -
Identifier Source: org_study_id
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