Acute Myocardial Infarction, Percutaneous Coronary Intervention
Conditions
Keywords
acute myocardial infarction, percutaneous coronary intervention, deferred stent implantation
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.
Interventions
DEVICEDeferred stent implantation
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
DEVICEImmediate stent implantation
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of cardiac death and recurrent myocardial infarction | 30 days after primary angiography | Recorded in follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactFeng Zhang, M.D.
Backup ContactYang Gao, M.D.
Outcome results
None listed