Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI

Not Applicable

• Conditions: Percutaneous Coronary Intervention; Acute Myocardial Infarction
• Interventions: Device: Deferred stent implantation; Device: Immediate stent implantation

• Registration Number: NCT03282773
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

This study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.

Detailed Description

Primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. Deferred stent implantation may improve prognosis of primary PCI through reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy.

This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.

Study Timeline

• Study First Submitted: 2017-09-10
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Status Verified: 2017-11
• Study Start: 2017-11-01
• Last Update Submitted: 2017-11-18
• Last Update Posted: 2017-11-21
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Clinical diagnosis of acute myocardial infarction occured within 12 hours
• Left main coronary artery occlusion confirmed by angiography
• Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation

Exclusion Criteria

• Life expectancy less than 1 years
• Cardiogenic shock
• Chronic kidney disease, stage 4 by KDOQI(GFR<30ml/min)
• Contraindications to aspirin or other anti-platelet drugs
• Allergy to contrast agent, rapamycin or paclitaxel
• Patients who are included in other ongoing trials
• Pregnant female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deferred stent implantation	Deferred stent implantation	Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI
Immediate stent implantation	Immediate stent implantation	Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery

Primary Outcome Measures

Name	Time	Method
Composite of cardiac death and recurrent myocardial infarction	30 days after primary angiography	Recorded in follow-up

Secondary Outcome Measures

Name	Time	Method
All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization	30 days after primary angiography	Recorded in follow-up
Residual stenosis of left main coronary artery	Immediately after stent implantation and 12 months after primary angiography	Measured through angiography
Left ventricular ejection fraction	30 days and 12 months after primary angiography	Measured through echocardiogram

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China