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Clinical Trials/NCT03282773
NCT03282773
Unknown
Not Applicable

Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion

Shanghai Zhongshan Hospital1 site in 1 country480 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Shanghai Zhongshan Hospital
Enrollment
480
Locations
1
Primary Endpoint
Composite of cardiac death and recurrent myocardial infarction
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
July 31, 2022
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composite of cardiac death and recurrent myocardial infarction

Time Frame: 30 days after primary angiography

Recorded in follow-up

Secondary Outcomes

  • All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization(30 days after primary angiography)
  • Residual stenosis of left main coronary artery(Immediately after stent implantation and 12 months after primary angiography)
  • Left ventricular ejection fraction(30 days and 12 months after primary angiography)

Study Sites (1)

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