NCT04626882

Brief Summary

Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
994

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
active not recruiting

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 Progress64%
Dec 2019Dec 2029

Study Start

First participant enrolled

December 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

November 2, 2020

Last Update Submit

May 24, 2025

Conditions

Myocardial Infarction, AcuteMulti-Vessel Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline

    Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention

    Index admission to 12 months

Secondary Outcomes (15)

  • Rate of contrast-induced nephropathy during index admission

    During index admission

  • Cumulative incidence rate of all unplanned revascularization at each visit

    Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Cumulative incidence rate of target-lesion revascularization at each visit

    Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Cumulative incidence rate of target-vessel revascularization at each visit

    Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Cumulative incidence rate of non-target vessel revascularization at each visit

    Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • +10 more secondary outcomes

Study Arms (2)

Staged in-hospital CR (complete revascularization)

ACTIVE COMPARATOR

Non-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Procedure: Staged in-hospital or Immediate complete revascularization

Immediate CR (complete revascularization)

EXPERIMENTAL

Non-infarct related artery (IRA) will be revascularized immediately after PCI for IRA (during primary PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Procedure: Staged in-hospital or Immediate complete revascularization

Interventions

Staged in-hospital or Immediate complete revascularizationPROCEDURE

Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Immediate CR (complete revascularization)Staged in-hospital CR (complete revascularization)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 19 years old
  • ST-segment elevation myocardial infarction
  • ST-segment elevation in at least 2 contiguous leads or,
  • New onset left bundle branch block
  • Primary PCI within 12 hours after symptom development
  • Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
  • Patient's or protector's agreement about study design and the risk of PCI

You may not qualify if:

  • Cardiogenic shock at initial presentation or after treatment of IRA
  • Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
  • TIMI (Thrombolysis in Myocardial Infarction) flow at non-IRA ≤ 2
  • Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
  • Non-IRA lesion not suitable for PCI treatment by operators' decision
  • Chronic total occlusion at non-IRA
  • History of anaphylaxis to contrast agent
  • Pregnancy and lactation
  • Life expectancy \< 1-year
  • Severe valvular disease
  • History of CABG (coronary artery bypass graft), or planned CABG
  • Fibrinolysis before admission
  • Severe asthma
  • Patient's refusal to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Yeongnam University Medical Center

Daegu, South Korea

Location

GangNeung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Presbyterian Medical Center

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Koera University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

St. Carollo General Hospital

Suncheon, South Korea

Location

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Related Publications (2)

  • Kim MC, Ahn JH, Hyun DY, Lim Y, Cho KH, Lee SH, Park S, Oh S, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Lee JH, Jeong YH, Ahn JH, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Park JI, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial. Lancet. 2025 Sep 6;406(10507):1032-1043. doi: 10.1016/S0140-6736(25)01529-6. Epub 2025 Aug 31.

    PMID: 40902612DERIVED

  • Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Oh S, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Jeong YH, Park Y, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Lee JH, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial. Am Heart J. 2024 Jul;273:35-43. doi: 10.1016/j.ahj.2024.03.017. Epub 2024 Apr 18.

    PMID: 38641031DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Youngkeun Ahn, MD

    Chonnam National University Hospital

    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
Associate Professor

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 13, 2020

Study Start

December 30, 2019

Primary Completion

January 15, 2025

Study Completion (Estimated)

December 31, 2029

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(14)