Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction

Phase 2

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Procedure: Angiography-guided PCI; Procedure: IVUS-guided PCI

• Registration Number: NCT04063345
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization.

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).

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29
• Study Start: 2021-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Clinical inclusion criteria:

  1. Age > 18 years
  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

• Angiographic inclusion criteria:

  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

• Clinical exclusion criteria:

  1. Contraindicating to any concomitant study medications
  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

• Anigographic Exclusion Criteria:

  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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography-guided PCI	Angiography-guided PCI	Percutaneous intervention under angiograhy-guidance only
IVUS-guided PCI	IVUS-guided PCI	Percutaneous intervention under IVUS-guidance

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac event (MACE) rate	1 year	Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)

Secondary Outcome Measures

Name	Time	Method
MI (Q-wave and non-Q-wave) rat	2-3 years
Cardiac death rate	2-3 years
Non-cardiac death rate	2-3 years
TVR rate	2-3 years
Target vessel failure (TVF) rate	2-3 years
MACE rate	2-3 years
Target lesion revascularization (TLR) rate	2-3 years
Target lesion failure (TLF) rate	2-3 years
All death (cardiac and non-cardiovascular) rate	2-3 years
Stent Thrombosis (ST) rate (ARC definite/probable)	2-3 years

Trial Locations

Locations (1)

Second affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China