The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction.
GUSTO Angiographic Investigators
https://pubmed.ncbi.nlm.nih.gov/8232430Actively Recruiting
Phase 4
Age: 19Years +
All Genders
ID05427786
A Randomized, Open Label, Parallel-group Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to Prevent Reduced TIMI Flow in Patients Undergoing Percutaneous Coronary Intervention for Coronary Artery Disease
Led by Korea University Anam Hospital · Updated on 2024-10-10
460
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of injecting nicorandil directly into the coronary artery before percutaneous coronary intervention (PCI) in patients with coronary artery disease who have high-risk plaques. The study focuses on preventing a decrease in coronary blood flow, measured by the TIMI flow, during the procedure. Participants are patients requiring stent treatment with a high lipid core burden index at the main lesion site. Participants with a lipid core burden index above 353 are randomly assigned to one of two groups. One group receives an intracoronary injection of at least 8cc of nicorandil before balloon therapy during PCI. The other group undergoes the standard PCI procedure without the nicorandil injection. The stent treatment method follows the usual clinical practice in both groups. During the study, researchers will monitor the occurrence of decreased TIMI flow during the procedure as the primary outcome. Secondary outcomes include changes in cardiac biomarker levels one month after intervention and several patient health measures such as mortality, cardiac death, myocardial infarction, and revascularization rates over one year. The study involves clinical follow-up and written consent for data use from participants, with the total duration including at least one year of follow-up.
CONDITIONS
Brief Title
A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT ReductioN of DecREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Over 19 years old
- Patients who agree to the study and clinical follow-up plan and provide written consent
- Patients who have undergone NIRS-IVUS guided coronary stent surgery for coronary artery disease
You will not qualify if you...
- Patients with TIMI flow less than or equal to 2 before coronary intervention
- Known allergies or contraindications to heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel, or contrast agents (except controlled hypersensitivity to contrast agents)
- Pregnant or breastfeeding women, or women planning pregnancy during the study
- Patients planning surgery to stop antiplatelet drugs within 6 months from registration
- Patients expected to survive less than 1 year
- Patients admitted due to cardiogenic shock with low survival probability according to medical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - Single procedure day
Participants undergo percutaneous coronary intervention. Those randomized to the Nicorandil group receive an intracoronary injection of Nicorandil before balloon therapy; others receive standard PCI without Nicorandil.
1 treatment visit (in-person)
Follow-up
Duration - Up to 1 year
Participants are monitored for changes in cardiac biomarkers and clinical outcomes including mortality and cardiac events over time.
Multiple follow-up visits including assessments at 1 month and periodic visits up to 1 year
Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Angiographic no-reflow phenomenon as a predictor of adverse long-term outcome in patients treated with percutaneous transluminal coronary angioplasty for first acute myocardial infarction.
I Morishima, T Sone, K Okumura...
https://pubmed.ncbi.nlm.nih.gov/11028471Incidence and treatment of 'no-reflow' after percutaneous coronary intervention.
R N Piana, G Y Paik, M Moscucci...
https://pubmed.ncbi.nlm.nih.gov/8205658Incidence and outcomes of no-reflow phenomenon during percutaneous coronary intervention among patients with acute myocardial infarction.
Robert W Harrison, Atul Aggarwal, Fang-shu Ou...
https://pubmed.ncbi.nlm.nih.gov/23111142Impact of ultrasound attenuation and plaque rupture as detected by intravascular ultrasound on the incidence of no-reflow phenomenon after percutaneous coronary intervention in ST-segment elevation myocardial infarction.
Mitsuaki Endo, Kiyoshi Hibi, Tomoaki Shimizu...
https://pubmed.ncbi.nlm.nih.gov/20488411From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I.
Morteza Naghavi, Peter Libby, Erling Falk...
https://pubmed.ncbi.nlm.nih.gov/14530185From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part II.
Morteza Naghavi, Peter Libby, Erling Falk...
https://pubmed.ncbi.nlm.nih.gov/14557340Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study.
David Erlinge, Akiko Maehara, Ori Ben-Yehuda...
https://pubmed.ncbi.nlm.nih.gov/33714389Coronary embolization following balloon dilation of lipid-core plaques.
James A Goldstein, Cindy Grines, Tim Fischell...
https://pubmed.ncbi.nlm.nih.gov/20083078Detection of lipid core coronary plaques in autopsy specimens with a novel catheter-based near-infrared spectroscopy system.
Craig M Gardner, Huwei Tan, Edward L Hull...
https://pubmed.ncbi.nlm.nih.gov/19356494