EUCTR2019-001995-12-IT进行中（未招募）1 期
Cardiac Arrhythmia catheter ablation procedures guided by x-Ray imaging: N-Acetylcysteine Protection Against radiation induced Cellular damagE (CARAPACE Study). - CARAPACE
CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO0 个研究点目标入组 550 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient’s age >18 years.
- •Indication to perform catheter ablation procedure guided by fluoroscopy (IR imaging).
- •Negative hCG pregnancy test (if appropriate).
- •Ability and willingness to give informed consent and to comply with protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 275
排除标准
- •Any contraindication to Catheter Ablation Procedure (such as, pregnancy and breastfeeding).
- •Hypersensitivity to the active substance or to any of the excipients.
- •Enrolment in another study that may interfere with CARAPACE study.
- •Administration of an experimental drug within 30 days or 5 half-lives of the investigational drug.
- •Chronic kidney disease (serum creatinine >1.5 mg/dl).
- •Acute/Chronic inflammatory disease.
- •Antioxidant drugs intake over the previous 2 weeks.
- •History of radiotherapy or chemotherapy in the last year.
- •Any documented condition that, in PI's motivated judgement, makes the patient a poor candidate for the study.
- •Computed tomography and/or coronary angiography within 5 days prior to baseline analysis.
研究者
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