Skip to content

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

OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in Non-ST-Segment Elevation Myocardial Infarction with Multivessel Disease (OPTION-NSTEMI)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006406
Enrollment
1014
Registered
2021-07-29
Start date
2021-09-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Among patients with non-ST-segment elevation myocardial infarction (NSTEMI), patients with non-infarct related artery (IRA) which has more than 50% diameter stenosis by visual asse

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age = 19 years old 2) Non-ST-segment elevation myocardial infarction ** Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and, # occurs at rest, usually lasting > 10 minutes # severe and new onset (within the prior 4-6 weeks) # crescendo pattern ** Elevated cardiac biomarkers and, # = 99% value of high-sensitivity cardiac troponin ** No ST-segment elevation = 0.1 mV in = 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram 3) PCI within 72 hours after symptom development 4) Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation 5) Patient's or protector's agreement about study design and the risk of PCI

Exclusion criteria

Exclusion criteria: 1) Cardiogenic shock at initial presentation or after treatment of infarct-related artery(IRA)* 2) Thrombolysis in Myocardial Infarction(TIMI) flow at non-IRA = 2 at initial coronary angiography 3) Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision 4) Non-IRA lesion not suitable for percutaneous coronary intervention(PCI) treatment by operators' decision 5) Chronic total occlusion at non-IRA 6) History of anaphylaxis to contrast agent 7) Pregnancy and lactation 8) Life expectancy < 1-year due to non-cardiac disease 9) Severe valvular disease 10) History of coronary artery bypass graft(CABG), or planned CABG 11) Severe asthma 12) Patient's refusal for study participation * The definition of cardiogenic shock 1) Systolic blood pressure(SBP) < 90mmHg for more than 30min, or needs for vasopressor to maintain equal or more than SBP 90mmHg 2) Pulmonary congestion, or increased left ventricular filling pressure by cardiac catheterization 3) At least one sign of impaired organ perfusion: mental obtundation, pallor, coldness, oliguria, increased blood lactate

Design outcomes

Primary

MeasureTime frame
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization

Secondary

MeasureTime frame
Contrast-induced nephropathy;All unplanned revascularization;Target-lesion revascularization;Target-vessel revascularization;Non-target vessel revascularization;All-cause death;Cardiac death;Non-cardiac death;Non-fatal myocardial infarction;Hospitalization for unstable angina;Hospitalization for heart failure;Definite or probable stent thrombosis by ARC definition;Ischemic and hemorrhagic stroke;Major bleeding (BARC classification 3 or 5)

Countries

Korea, Republic of

Contacts

Public ContactMin Chul Kim

Chonnam National University Hospital

kmc3242@hanmail.net+82-62-220-6578

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026