Coronary Artery Disease, No-Reflow Phenomenon, Percutaneous Coronary Intervention
Conditions
Keywords
Nicorandil, No-reflow phenomenon, lipid core burden index, near-infrared spectroscopy
Brief summary
The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.
Interventions
DRUGNicorandil
Administer 8cc or more of the prescribed drug according to randomization into the coronary artery before starting balloon therapy. The stent treatment method follows the standard treatment method.
Sponsors
Korea University Anam Hospital
Hanyang University Seoul Hospital
InjeUniversityIlsanPaikHospital
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
A Multi-center, Open Label, Randomized, Parallel-group Study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 19 years old 2. Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information 3. Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease 4. maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS
Exclusion criteria
1. Patients with TIMI ≤ 2 before coronary intervention 2. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.) 3. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 4. Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration 5. Those whose surviving life is expected to be less than 1 year 6. Subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of decreased TIMI flow | during procedure | occurrence of decreased TIMI flow (0,1,2) during the index procedure Grade 0-No perfusion Grade 1-Penetration without perfusion Grade 2-Partial perfusion but not reach complete perfusion Grade 3-Complete perfusion;; antegrade flow into the bed distal to the obstruction occurs as promptly as antegrade flow into the bed proximal to the obstruction, and clearance of contrast material from the involved bed is as rapid as clearance from an uninvolved bed in the same vessel or the opposite artery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of cardiac biomarker level after intervention | 1 month | level change of CPK |
| patient-oriented composite end point | 1 year | composite of all cause mortality, any myocardial infarction, and any revascularization |
| Percentage of All cause mortality | 1 year | — |
| Percentage of cardiac death | 1 year | — |
| Percentage of myocardial infarction | 1 year | — |
| Percentage of revascularization | 1 year | — |
Countries
South Korea
Outcome results
None listed