Evaluating revascularization strategies for patients with NSTEMI and multivessel coronary artery disease
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)
This study is testing whether treating all blocked heart arteries right away or doing it in stages is better for people with NSTEMI and multiple blocked arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1014 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chonnam National University Hospital Academic / other |
| Locations | 1 site (Gwangju) |
| Trial ID | NCT04968808 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of two different revascularization strategies in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (MVD). Participants will be randomly assigned to receive either immediate complete revascularization during the initial procedure or a staged approach where non-infarct-related arteries are treated later. The study will utilize fractional flow reserve (FFR) to guide interventions for certain lesions. The goal is to determine which strategy leads to better clinical outcomes for patients with this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who have experienced NSTEMI and have multivessel coronary artery disease.
Not a fit: Patients presenting with cardiogenic shock or severe procedural complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with NSTEMI and MVD, potentially enhancing their recovery and long-term health outcomes.
How similar studies have performed: Previous studies have shown promising results for similar revascularization strategies, but this specific approach in NSTEMI and MVD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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:
1. Cardiogenic shock at initial presentation or after treatment of IRA
2. TIMI flow at non-IRA ≤ 2
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 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
9. Severe valvular disease
10. History of CABG, or planned CABG
11. Fibrinolysis before admission
Where this trial is running
Gwangju
- Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
Study contacts
- Principal investigator: Min Chul Kim, MD — Chonnam National University Hospital
- Study coordinator: Min Chul Kim, MD
- Email: kmc3242@hanmail.net
- Phone: 82-62-220-6578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.