Clinical Research Directory

Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial

The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI). Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.

For Patients With Myocardial Infarction and Multiple Vessel: Testing if Ultrasound (UFR) Can Guide All Needed Treatment in One Procedure, Avoiding a Return Hospital Visit for a Second Operation.

Brief Summary The Purpose of the Study : The purpose of this study is to find a safe and reliable "one-stop" solution for treating heart attack patients who have multiple blocked arteries. Currently, doctors face a dilemma: Testing these other blockages during the heart attack procedure is often unreliable. The most accurate method requires asking the patient to return 30 days later for a second invasive procedure, which is a significant burden. The Study's Hypothesis : We are testing a new tool called UFR, which uses ultrasound images to measure blockages. Our hypothesis (or "educated guess") is that this new UFR tool is not affected by the body's stress during a heart attack and can provide a true, reliable measurement right away. The Question the Study is Trying to Answer ： The main question this study is trying to answer is: Can the new "one-stop" UFR tool, used during the initial heart attack procedure, accurately predict which blockages are truly serious... thereby eliminating the need for patients to return for a second procedure 30 days later? Researchers will also follow 200 patients for one year, using advanced scans (like UFR, standard tests, and MRI), to better understand how the heart and arteries heal and change over time.

Effects of Early Vagus Nerve Stimulation on Infarct Damage and Functioning After Acute STEMI

The goal of this clinical trial is to investigate whether early non-invasive vagus nerve stimulation (nVNS) can reduce infarct damage and improve functioning after acute ST-elevation myocardial infarction (STEMI). It will assess the safety and effectiveness of nVNS in improving cardiac outcomes. The main questions it aims to answer are: * Does nVNS improve short-term prognosis post-STEMI by enhancing heart rate variability (HRV) and reducing inflammation? * Does nVNS reduce infarct size, improve left ventricular function, and lower inflammatory markers compared to sham stimulation? Participants will be randomly assigned to one of two groups: * Experimental group: Receive standard care plus nVNS for 60 minutes at the right ear using the Parasym device under ECG monitoring. * Control group: Receive standard care plus sham nVNS (placebo-like procedure without stimulation). Participants will undergo stimulation once for 60 minutes post-percutaneous coronary intervention (PCI), and be monitored for adverse reactions like bradycardia, with immediate cessation if needed. Key study details: * Inclusion criteria: Adults aged 25-75 years with confirmed STEMI (clinical signs and elevated troponin). * Exclusion criteria: Bradycardia (HR \< 50 bpm), extensive anterior MI, hypotension, or severe cardiac/medical conditions. * Intervention parameters: Stimulation targeting the auricular branch of the vagal nerve with 200µs pulse width, 20Hz frequency, and adjustable intensity (10-50mA), remaining below the pain threshold. Outcomes measured: * Primary outcomes: Wall motion score index (WMSI) and left ventricular ejection fraction (LVEF). * Secondary outcomes: HRV metrics, troponin levels, inflammatory markers (CRP, NLR), atrial fibrillation events, hospitalization duration, one-month survival, quality of life (HeartQOL scale), and one-year survival. Statistical analysis: Researchers will compare baseline characteristics using t-tests and chi-square tests. Main analyses will involve repeated measures mixed-design ANOVA and multivariate ANOVA. Moderation analysis will assess the influence of the experimental condition on inflammation and clinical outcomes. Ethical considerations: The study complies with Israeli Ministry of Health guidelines for emergency clinical trials. Participants will provide verbal consent followed by written consent. Ethical approval was granted by the IRB of Bnai Zion Medical Center, Haifa, Israel (Approval No. 0169-21-BNZ).

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

For patients with anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), whether early application of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (LDL-C) before PCI could effectively inhibit left ventricular remodeling has been rarely reported. The aim of this study was to investigate the effect of early application of PCSK9 inhibitors Evolocumab to rapidly reduce LDL-C levels before primary PCI treatment on left ventricular remodeling in STEMI patients. Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.