A Prospective, Multicenter, Single-arm, Open Label, Study to Determine Cardiac MRI-Guided Deferiprone Therapy for Acute Myocardial Infarction Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- 1)To assess the Percentage reduction of hemorrhagic zone heme content by using Late Gadolinium Enhancement (LGE) contrast based Cardiac Magnetic Resonance Imagining (MRI) T2 mapping weighted images and quantification
研究概览
简要总结
This prospective Investigator Initiated Trial (IIT) study, multicenter, single arm, open-label study aims to evaluate Cardiac MRI-guided Deferiprone therapy for acute myocardial infarction (MI) patients. The study will commence at each site following Ethics Committee (EC) approval. 30 Newly diagnosed STEMI patients who have recently undergone PCI will be approached for the screening procedure. Written informed consent will be obtained before any study-related procedures by the clinical site team are performed.
This study will be conducted in compliance with the Protocol, Good Clinical Practice (GCP) as set forth in the International Council for Harmonization (ICH) guidelines on GCP (ICH E6 (R3)) and applicable local regulatory requirements
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either gender, aged 18 to 75 years (both inclusive) 2)Patient with no physical limitation to ingest and retain oral medication 3)New or newly diagnosed patients with ST Elevation Myocardial Infarction (STEMI) confirmed by electrocardiogram (ECG) 4)Patients recently underwent primary Percutaneous Coronary Intervention (PCI) 5)Patients who understand & willing to comply with study requirements and provide written informed consent for participation 6)Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy.
排除标准
- •Prior history of MI / PCI / coronary artery bypass graft (CABG) 2)Patients with previous history of left ventricular ejection fraction less then 40% 3)Patients with eGFR less than 30 ml/min/1.73m2 at screening.
- •Patients with Absolute Neutrophil Count (ANC) less than 1.0 x 109 /L at screening 5)Elevated hepatic enzymes like Alkaline phosphatase (ALT) and/or aspartate aminotransferase (AST) more than 2 times of upper normal limit and not taking medications for chronic liver disease.
- •Patients with Body weight more than 140 kg (or 309 lbs.) at screening 7)Any contraindication against cardiac MRI (such as metal implants etc.) and known allergy or contra-indication to gadolinium/contrast agents.
- •Patients with heme storage disease (hemochromatosis, thalassemia) or who are already treated with heme deactivators.
- •Patient with history of HIV and or Hepatitis B and or Hepatitis C.
- •Participation in any experimental drug and or device study within 60 days before screening.
- •Any clinically significant abnormality identified prior to enrollment in the judgment of the 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 noncardiac pathology.
- •The presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcome parameter data.
结局指标
主要结局
1)To assess the Percentage reduction of hemorrhagic zone heme content by using Late Gadolinium Enhancement (LGE) contrast based Cardiac Magnetic Resonance Imagining (MRI) T2 mapping weighted images and quantification
时间窗: Baseline and Day 90 ± 3 days
2)To assess the Percentage changes in Infarct Size and Left Ventricular Ejection Fraction (LVEF) using Late Gadolinium Enhancement (LGE) contrast based Cardiac MRI
时间窗: Baseline and Day 90 ± 3 days
次要结局
- Incidence of adverse events & serious adverse events(From Baseline to Day 90 ± 3 days)
研究者
Dr Kinjal Bhatt
Synergy Superspecialty Hospital