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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04063345

Collaborator

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)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Procedure: IVUS-guided PCI Procedure: Angiography-guided PCI	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open Label, Multicenter and Randomized Study of Clinical Outcomes of Intravascular Ultrasound -Guided and Angiography-Guided Primary Percutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IVUS-guided PCI Percutaneous intervention under IVUS-guidance	Procedure: IVUS-guided PCI Performing intravascular ultrasound before or/and after percutaneous intervention
Active Comparator: Angiography-guided PCI Percutaneous intervention under angiograhy-guidance only	Procedure: Angiography-guided PCI Performing percutaneous intervention without intravascular ultrasound guidance

Arm

Intervention/Treatment

Experimental: IVUS-guided PCI

Percutaneous intervention under IVUS-guidance

Procedure: IVUS-guided PCI

Performing intravascular ultrasound before or/and after percutaneous intervention

Active Comparator: Angiography-guided PCI

Percutaneous intervention under angiograhy-guidance only

Procedure: Angiography-guided PCI

Performing percutaneous intervention without intravascular ultrasound guidance

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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 Exclusion Criteria:

Bifurcated lesion unable to identify the culprit lesion
The culprit lesion is located in the left main artery
Diffusive lesions without distinguishable culprit lesion
Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
Likely CABG procedure within 30 days
Renal failure requiring or during dialysis