Clinical trial NCT03282773: Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI
Official title: Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Percutaneous Coronary Intervention
Keywords: acute myocardial infarction
percutaneous coronary intervention
deferred stent implantation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite of cardiac death and recurrent myocardial infarction
timeFrame: 30 days after primary angiography
Secondary outcomes:
measure: All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization
timeFrame: 30 days after primary angiography
measure: Residual stenosis of left main coronary artery
timeFrame: Immediately after stent implantation and 12 months after primary angiography
measure: Left ventricular ejection fraction
timeFrame: 30 days and 12 months after primary angiography
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital,Shanghai
name: Junbo Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao Y, Zhang F, Li C, Dai Y, Yang J, Qu Y, Qian J, Ge J; OPTIMAL trial investigators. Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial. Trials. 2019 Mar 8;20(1):162. doi: 10.1186/s13063-019-3211-0.