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

Zhejiang University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: ST Elevation Myocardial Infarction

Treatments: Procedure: IVUS-guided PCI; Procedure: Angiography-guided PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT04063345

SAHZJU CT015

Details and patient eligibility

About

To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

IVUS-guided PCI

Experimental group

Description:

Percutaneous intervention under IVUS-guidance

Treatment:

Procedure: IVUS-guided PCI

Angiography-guided PCI

Active Comparator group

Description:

Percutaneous intervention under angiograhy-guidance only

Treatment:

Procedure: Angiography-guided PCI