Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Treatment Efficacy
研究概览
简要总结
The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.
详细描述
Patients with newly diagnosed STEMI (ST-segment elevation myocardial infarction) who appear to meet eligibility criteria will be recruited for participation. Those who agree to participate and are confirmed to be eligible will undergo a cardiac MRI scan and will be randomized to take either deferiprone or placebo daily for 60 days. Total study participation will last 6 months, during which study participants will attend 7 study visits for blood draws, ECGs, and a repeat cardiac MRI at Day 180.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、医护人员、研究者)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- At least 18 years of age
- Index Anterior wall STEMI
- Emergency coronary angiogram with primary PCI
排除标准
- Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year
- Patients with previous history of left ventricular ejection fraction (LVEF) < 40%
- Use of investigational drugs or devices 30 days prior to randomization
- Known allergy or contra-indication to gadolinium/contrast agents
- eGFR < 30 ml/kg/min
- Any contraindication against cardiac MRI (such as metal implants)
- Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
- Body weight > 140 kg (or 309 lbs.)
- Absolute neutrophil count - ANC < 1.5 k/cumm
- History of Chronic Liver Disease
- Elevated hepatic enzymes (BOTH ALT and AST) > 2 times of upper normal limit
- Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators
- Any clinically significant abnormality identified prior to randomization that in the judgment of the Sponsor-Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone.
- Life expectancy of less than 1 year due to non-cardiac pathology
研究组 & 干预措施
Hemorrhagic Myocardial Infarction - Deferiprone
Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage
干预措施: Deferiprone Tablets (Drug)
Hemorrhagic Myocardial Infarction - Placebo
Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage
干预措施: Placebo (Drug)
Non-hemorrhagic Myocardial Infarction - Placebo
Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage
干预措施: Placebo (Drug)
Non-hemorrhagic Myocardial Infarction - Deferiprone
Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage
干预措施: Deferiprone Tablets (Drug)
结局指标
主要结局
Treatment Efficacy
时间窗: 6 months
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline
次要结局
- Safety and Tolerability - Rate of Discontinuation(6 months)
- Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity(6 months)
- Safety and Tolerability - Severe Side Effects(6 months)
- Safety and Tolerability - Reversibility of Side Effects without Treatment(6 months)
- Treatment Effect: Clinical Outcomes of Acute Heart Failure(6 months)
研究者
Rohan Dharmakumar
Executive Director, Medical Imaging Research Institute
Indiana University
研究点 (2)
标识符
- NCT 编号
- NCT05604131
- 其他研究编号
- 13487, 2R01HL133407-05
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (2个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否