Dexrazoxane for the Reduction of Haemorrhagic Myocardial Infarction in STEMI: A Double-Blind, Placebo-Controlled, Sequential-Cohort Phase IIa Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
This Phase Ila trial evaluates whether the intravenous administration of Dexrazoxane can reduce permanent heart muscle damage in patients undergoing standard stent procedures (PCI) for a severe heart attack (STEMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adult (18 - 79 years).
- •First STEMI (EMS/ER ECG ST-elevation) with primary PCI planned.
- •Consent pathway available: Patient consent, Legally Acceptable Representative (LAR)
- •CMR likely be feasible (no known MRI-unsafe implant or absolute MRI prohibition)
排除标准
- •History of PCI or CABG within 1 year
- •Known dialysis/ESRD
- •Known pre-existing LVEF <40% from recent records
- •Known pregnancy or breastfeeding (history or clearly documented)
- •Current anthracycline chemotherapy or active chest radiation (per patient/chart).
- •On iron chelation now or documented iron-storage disease (hemochromatosis/thalassemia).
- •Concurrent trials: investigational drug or device use within 90 days.
- •Any clinically significant condition identified that would preclude safe peri-procedural administration of Dexrazoxane or completion of core protocol procedures.
研究组 & 干预措施
Placebo Infusion
Participants receive an intravenous infusion of Normal Saline (0.9% NaCl) - visually identical to the investigational product - in the emergency room prior to primary PCI, followed by doses at 4, 8, and 12 hours post-primary PCI, adjunctive to standard of care.
干预措施: Normal Saline (Drug)
Dexrazoxane Infusion
Participants receive an intravenous infusion of Dexrazoxane in the ER, followed by doses at 4, 8, and 12 hours post-primary PCI.
干预措施: Dexrazoxane (Drug)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: From Baseline (48 to 72 hours post-PCI) to 3 Months
Left Ventricular Ejection Fraction (LVEF) expressed as a percentage. Quantified utilizing steady-state free precession (bSSFP) CMR volumetry. This measure evaluates the absolute change in global systolic function from the acute baseline phase to the follow-up phase, comparing the Dexrazoxane infusion versus the Placebo infusion.
Intramyocardial Hemorrhage Burden (IMH %LV)
时间窗: 48-72 hours post-primary PCI
Volume of intramyocardial hemorrhage expressed as a percentage of total left ventricular myocardial mass, measured by T2\* CMR
次要结局
- Change in Myocardial Infarct Size(From Baseline (48 to 72 hours post-PCI) to 3 Months)
- Incidence of Major Bleeding(From First Dose through 30 Days)
研究者
Rohan Dharmakumar
Executive Director, Medical Imaging Research Institute
Indiana University