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

Acute Myocardial Infarction Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03282773
• Other study ID #: B2017-104
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2017
• Last updated: November 18, 2017
• Start date: November 1, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: November 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Feng Zhang, M.D.
• Phone: 13917149007
• Email: zhang.feng[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Occlusion
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

Device:
• Deferred 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.
• Immediate 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.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiac death and recurrent myocardial infarction	Recorded in follow-up	30 days after primary angiography
Secondary	All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization	Recorded in follow-up	30 days after primary angiography
Secondary	Residual stenosis of left main coronary artery	Measured through angiography	Immediately after stent implantation and 12 months after primary angiography
Secondary	Left ventricular ejection fraction	Measured through echocardiogram	30 days and 12 months after primary angiography