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

November 18, 2017 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yang Gao, M.D.
  • Phone Number: 18801970322
  • Email: gysc20@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan hospital
        • Principal Investigator:
          • Junbo Ge, M.D.
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Feng Zhang, M.D.
        • Sub-Investigator:
          • Yang Gao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Active Comparator: Immediate stent implantation
Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of cardiac death and recurrent myocardial infarction
Time Frame: 30 days after primary angiography
Recorded in follow-up
30 days after primary angiography

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Junbo Ge, M.D., Zhongshan Hospital,Shanghai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

September 10, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 18, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2017-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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