NCT03571269

Brief Summary

Brief Summary: This study is a prospective, multicenter, randomized, controlled trial aimed to compare the reperfusion strategy and clinical outcomes of STEMI patients treated by angiography-guided vs. OCT-guided PCI. Patients presenting STEMI with coronary artery diameter stenosis ≤70% and TIMI blood flow grade 3 at index or after thrombus aspiration are randomly assigned to either an OCT-guided group or an angiography-guided group. In OCT-guided group, stent implantation or conservative medical treatment is determined based on OCT findings. Conservative non-stenting strategy will be recommended in those with culprit plaque erosions, certain ruptures without dissection and hematoma, SCAD without obstructive stenosis. In the angiography-guided group, reperfusion strategy is decided by the operators according to the local practice. The rate of stenting during primary PCI and clinical outcomes at 1-month and 1-year are collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2020

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

June 15, 2018

Last Update Submit

August 16, 2021

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

STEMI; optical coherence tomography; reperfusion

Outcome Measures

Primary Outcomes (2)

  • Primary effective endpoint of OCT-guided reperfusion strategy (powered)

    Patient-level rate of stent implantation between the two groups

    Immediate after primary PCI

  • Primary safety endpoint of OCT-guided reperfusion strategy

    The incidence of recurrent myocardial ischemic events (unstable angina-induced rehospitalization, recurrent myocardial infarction, target lesion revascularization) or cardiac death.

    Within 1 month

Secondary Outcomes (2)

  • Incidence of cardiocerebrovascular events

    Within 1 year

  • Incidence of heart failure event

    Within 1 year

Study Arms (2)

OCT-guided group

EXPERIMENTAL

Detailed methods of OCT examination are the same as above. Whether stenting or not will be decided by the operators according to the underlying mechanisms of culprit lesions. If stenting, OCT will be used to guide and optimize the whole process of PCI. Patients will be treated with dual antiplatelet therapy (aspirin+ticagrelor or aspirin+clopidogrel) for at least 12 months.

Procedure: Optical coherence tomography-guided reperfusion strategy

Angiography-guided group

NO INTERVENTION

Detailed methods of angiography examination are the same as above. Whether stenting or not and the whole process of PCI will be decided by the operators according to the current treatment standard of angiography. Patients will be treated with dual antiplatelet therapy (aspirin+ticagrelor or aspirin+clopidogrel) for at least 12 months.

Interventions

Optical coherence tomography-guided reperfusion strategyPROCEDURE

Optical coherence tomography will be used to detect the detailed characteristics of culprit lesion and to decide and optimize the reperfusion strategy according to the established algorithm in the protocol.

OCT-guided group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old ≤ age ≤ 80 years old;
  • Patients with STEMI\<12h;
  • The target lesion is located in a native coronary artery;
  • The residual diameter stenosis (DS) is ≤70% on angiogram and thrombolysis in myocardial infarction (TIMI) flow grade is 3 after thrombus aspiration or not;
  • Written informed consent.

You may not qualify if:

  • Patients who are breastfeeding or pregnant or planning to pregnant during the study period;
  • Patients with a history of heart failure;
  • Hemodynamic instability;
  • Target lesion such as: left main coronary artery; three-vessel disease; ostial lesion (defined as within 3mm of the left main coronary artery or aorto-ostium); tortuous lesion; angular lesion;
  • Subjects with contraindication of contrast medium;
  • There are contraindications to aspirin or clopidogrel;
  • Severe hepatic and renal insufficiency (ALT or AST \>3x upper limits of normal, creatinine\>2.0 mg/dL or end-stage renal disease);
  • Patients with bleeding tendency such as peptic ulcer, bleeding or coagulation disorders;
  • AMI is caused by surgery, trauma, gastrointestinal bleeding, PCI, or its complications;
  • AMI occurs in patients who have been hospitalized for other reasons;
  • Patients who were considered with poor compliance and could not complete the study as required judged by the investigators;
  • Patient with life expectancy ≤24 months;
  • Patients with heart transplantation;
  • Patients with definite diagnosis of tumors;
  • Patients who are currently enrolled in other clinical trial (except other subjects in this project) which has not reached its primary endpoint;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Daqing Oil Field Hospital

Daqing, Heilongjiang, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Hospital of Jilin University

Jilin, Jilin, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Related Publications (1)

  • Jia H, Dai J, He L, Xu Y, Shi Y, Zhao L, Sun Z, Liu Y, Weng Z, Feng X, Zhang D, Chen T, Zhang X, Li L, Xu Y, Wu Y, Yang Y, Wang C, Li L, Li J, Hou J, Liu B, Mintz GS, Yu B. EROSION III: A Multicenter RCT of OCT-Guided Reperfusion in STEMI With Early Infarct Artery Patency. JACC Cardiovasc Interv. 2022 Apr 25;15(8):846-856. doi: 10.1016/j.jcin.2022.01.298. Epub 2022 Mar 30.

    PMID: 35367176DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Bo Yu

    The Second Affiliated Hospital of Harbin Medical University

    STUDY CHAIR

  • Bin Liu

    Second Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

  • Jianping Li

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Yanqing Wu

    Second Affiliated Hospital of Nanchang University

    PRINCIPAL INVESTIGATOR

  • Ling Li

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

  • Chunmei Wang

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

  • Yin Liu

    Tianjin Chest Hospital

    PRINCIPAL INVESTIGATOR

  • Dajun Yuan

    The Second Affilated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

  • Zhiqi Sun

    Daqing Oil Field Hospital

    PRINCIPAL INVESTIGATOR

  • Yining Yang

    First Affiliated Hospital of Xinjiang Medical University

    PRINCIPAL INVESTIGATOR

  • Xinshun Gu

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

  • Lang Li

    First Affiliated Hospital of Guangxi Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 27, 2018

Study Start

December 21, 2017

Primary Completion

January 2, 2020

Study Completion

December 24, 2020

Last Updated

August 19, 2021

Record last verified: 2021-08

Locations

CN(12)