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Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)

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ClinicalTrials.gov Identifier: NCT04626882
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Min Chul Kim, Chonnam National University Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction, Acute Multi-Vessel Coronary Artery Stenosis Procedure: Staged in-hospital or Immediate complete revascularization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease (OPTION-STEMI)
Actual Study Start Date : December 31, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Staged in-hospital CR (complete revascularization)
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
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.

Experimental: Immediate CR (complete revascularization)
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
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.




Primary Outcome Measures :
  1. Cumulative incidence rate of all-cause death, non-fatal spontaneous myocardial infarction, or all unplanned revascularization at 1 year from baseline [ Time Frame: Index admission to 12 months ]
    Composite endpoint of all-cause death, non-fatal spontaneous myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention


Secondary Outcome Measures :
  1. Rate of contrast-induced nephropathy during index admission [ Time Frame: During index admission ]
    Rate of contrast-induced nephropathy during index admission

  2. Cumulative incidence rate of all unplanned revascularization at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of all unplanned revascularization at each visit

  3. Cumulative incidence rate of target-lesion revascularization at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of target-lesion revascularization at each visit

  4. Cumulative incidence rate of target-vessel revascularization at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of target-vessel revascularization at each visit

  5. Cumulative incidence rate of non-target vessel revascularization at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of non-target vessel revascularization at each visit

  6. Cumulative incidence rate of all-cause death at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of all-cause death at each visit

  7. Cumulative incidence rate of cardiac death at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of cardiac death at each visit

  8. Cumulative incidence rate of non-cardiac death at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of non-cardiac death at each visit

  9. Cumulative incidence rate of non-fatal spontaneous myocardial infarction at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of non-fatal spontaneous myocardial infarction at each visit

  10. Cumulative incidence rate of hospitalization for unstable angina at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of hospitalization for unstable angina at each visit

  11. Cumulative incidence rate of hospitalization for heart failure at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of hospitalization for heart failure at each visit

  12. Cumulative incidence rate of definite or probable stent thrombosis at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of definite or probable stent thrombosis at each visit

  13. Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit

  14. Cumulative incidence rate of major bleeding (BARC definitions type 2, 3 or 5) at each visit [ Time Frame: Index admission, 1 month, 6 months, 12 months ]
    Cumulative incidence rate of major bleeding (BARC definitions type 2, 3 or 5) at each visit



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626882


Contacts
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Contact: Min Chul Kim, MD +82-62-220-6578 kmc3242@hanmail.net
Contact: Kyoung Hee Mun, CRC +82-62-220-6273 violet2570@naver.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
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Principal Investigator: Youngkeun Ahn, MD Chonnam National University Hospital
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Responsible Party: Min Chul Kim, Associate Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT04626882    
Other Study ID Numbers: CNUH-2019-318
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Coronary Stenosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease