A Comparative Study of Colchicine's Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients: Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI
研究概览
简要总结
This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction. Through a clinical trial involving patients requiring coronary intervention, we explore how Colchicine can reduce inflammation and fibrosis, two crucial factors influencing heart failure post-heart attack. The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure.
详细描述
This clinical trial, a prospective, focuses on patients with ST-Elevation Myocardial Infarction (STEMI) requiring Percutaneous Coronary Intervention (PCI) within 12 hours of onset. The study aims to control bias effectively through randomization, evenly distributing confounding factors across two groups. Patients, unknown to both researchers and themselves whether receiving Colchicine or a placebo, will undergo reperfusion therapy and optimal medicinal treatment according to the latest guidelines. The study population includes all STEMI patients in three cities in East Java (Jember, Malang, Tulungagung), selected through purposive sampling. The independent variable is Colchicine administration, while dependent variables include ventricular remodeling assessed by Left Ventricular End-Diastolic Volume (LVEDV) via echocardiography, serum levels of caspase-1, TGF-β, NT pro BNP and Galectin-3. All patients receive standard medical treatment pre-PCI, including aspirin and antiplatelet drugs, with post-PCI Optical Medical Treatment (OMT) following the latest guidelines.
The trial is randomized, double-blinded, and placebo-controlled, with participants divided into four groups: early PCI with Colchicine or placebo, and STEMI without reperfusion, receiving either Colchicine or placebo. This setup allows for a comprehensive comparison across different patient management strategies, exploring Colchicine's potential benefits in post-AMI care and its effects on key inflammatory and fibrotic markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The subjects of this study are patients with ST-Elevation Myocardial Infarction (STEMI) who have undergone Percutaneous Coronary Intervention (PCI) and those without reperfusion. Subject selection was conducted using purposive sampling. Patients who received early PCI without reperfusion were divided into four groups: 1). Early PCI with Colchicine, 2). Early PCI with placebo, 3). STEMI without reperfusion with Colchicine and STEMI without reperfusion with placebo. This approach aims to rigorously evaluate the effects of Colchicine in managing inflammation and cardiac remodeling in STEMI patients, comparing its efficacy against standard placebo treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 years or older. Able and willing to provide informed consent. Presenting with clinical symptoms and supporting examinations indicative of a first-time diagnosis of IMA-EST.
- •Eligible for treatment according to the IMA-STEMI guidelines, which may include:
- •Antiplatelet therapy Renin-angiotensin-aldosterone system inhibitors Beta-blockers
- •Specifically, includes patients who have:
- •Undergone early PCI. Not received reperfusion therapy. Female patients must commit to avoiding pregnancy during the study. Willing to participate in follow-up via face-to-face or telephone contact.
排除标准
- •Presence of concurrent diseases such as infections, inflammation, or malignancy.
- •Diagnosed with gastrointestinal disorders including Crohn's disease, ulcerative colitis, or exhibiting chronic diarrhea.
- •Recent abnormal laboratory results (within the last 30 days) including:
- •Hemoglobin below 11.5 g/L Leukocytes below 3.0 x 10^9/L Platelets below 110 x 10^9/L ALT more than three times the upper limit of normal Total bilirubin more than twice the upper limit of normal Creatinine more than twice the upper limit of normal History of liver cirrhosis, acute hepatitis exacerbation, or severe liver disease.
- •Currently pregnant, breastfeeding, or planning to become pregnant during the study.
- •History of alcohol abuse. Receiving long-term steroid therapy or using colchicine for other indications. History of hypersensitivity to colchicine. Severe renal failure (eGFR below 30). History of cardiac arrest, ventricular fibrillation, cardiogenic shock, or hemodynamic instability.
- •Unwilling or unable to provide informed consent.
研究组 & 干预措施
Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI
Patients receive colchicine according to protocol: Loading dose of 1 mg 1-2 hours before PCI, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT
干预措施: Colchicine 0.5 MG Oral Tablet (Drug)
Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI
Patients receive placebo according to protocol: Placebo administration and OMT
干预措施: Colchicine 0.5 MG Oral Tablet (Drug)
Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion
Patients receive colchicine according to protocol: Loading dose of 1 mg, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT
干预措施: Colchicine 0.5 MG Oral Tablet (Drug)
Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion
Patients receive placebo according to protocol: Placebo administration and OMT
干预措施: Colchicine 0.5 MG Oral Tablet (Drug)
结局指标
主要结局
mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI
时间窗: Baseline and 1 month post-intervention
This study assesses the impact of colchicine on ventricular remodeling by measuring changes in the expression of NLRP3 inflammasome, TGF-β, and galectin-3. These biomarkers are indicative of inflammation and fibrotic activity affecting ventricular structure and function in acute STEMI patients post-PCI or without reperfusion therapy
次要结局
未报告次要终点
研究者
Tri Astiawati
Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia
University of Brawijaya