Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)
Launched by CHONNAM NATIONAL UNIVERSITY HOSPITAL · Nov 6, 2020
Trial Information
Current as of July 04, 2025
Active, not recruiting
Keywords
ClinConnect Summary
The OPTION-STEMI trial is studying the best timing for a heart procedure called PCI (percutaneous coronary intervention) in patients who have had a heart attack known as STEMI (ST-segment elevation myocardial infarction) and also have blockages in multiple heart arteries. In this trial, patients will be randomly assigned to one of two groups: one group will have all their blockages treated right away, while the other group will have their treatments staged over time. Depending on the severity of the blockages, some may need additional tests to decide if treatment is necessary. This trial aims to find out which approach is better for patients’ recovery and heart health.
To be eligible for this trial, participants must be at least 19 years old and have experienced a STEMI heart attack within the last 12 hours. They should also have blockages in at least two heart arteries. Patients who have certain severe conditions, like severe heart failure or specific complications from their heart attack, will not be eligible. Those who do participate can expect close monitoring and care from the medical team throughout the study, as well as the chance to contribute to important research that may improve treatment for future patients with similar conditions.
Gender
ALL
Eligibility 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
- • Patient's refusal to participate in study
About Chonnam National University Hospital
Chonnam National University Hospital, a leading medical institution in South Korea, is at the forefront of clinical research and innovation. As a sponsor of clinical trials, the hospital leverages its robust academic resources and multidisciplinary expertise to advance medical knowledge and improve patient care. With a commitment to ethical standards and patient safety, Chonnam National University Hospital collaborates with various stakeholders in the healthcare community to conduct rigorous studies that explore new therapies and treatment modalities. Its state-of-the-art facilities and dedicated research teams contribute to the successful execution of trials across a wide range of medical disciplines.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Incheon, , Korea, Republic Of
Jinju, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Pusan, , Korea, Republic Of
Gangneung, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bucheon, , Korea, Republic Of
Daegu, , Korea, Republic Of
Incheon, , Korea, Republic Of
Changwon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Pusan, , Korea, Republic Of
Suncheon, , Korea, Republic Of
Uijeongbu, , Korea, Republic Of
Wonju, , Korea, Republic Of
Patients applied
Trial Officials
Youngkeun Ahn, MD
Principal Investigator
Chonnam National University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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