NCT06117046已完成4 期
The Cardio-protective Effect of Cardiomyopeptidin on Myocardial Injury in ICU Patients With Non-organic Heart Disease: a Prospective, Randomized Controlled Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- major adverse cardiac events
研究概览
简要总结
The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
- •Obtain the informed consent of the subject or legal agent
排除标准
- •Patients who are expected to die within 48 hours of ICU admission
- •previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
- •cardiopulmonary resuscitation and/or electrical defibrillation before admission
- •patients with acute ischemic stroke
- •patients with stage 5 chronic kidney disease
- •during pregnancy or breastfeeding
研究组 & 干预措施
Cardiopeptidin
Experimental
Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days
干预措施: Cardiopeptidin (Drug)
50 ml of normal saline intravenous infusion
Placebo Comparator
50 ml of normal saline intravenous infusion.
干预措施: 50 ml of normal saline intravenous infusion (Drug)
结局指标
主要结局
major adverse cardiac events
时间窗: On the day of enrollment, until 28 days.
major adverse cardiac events
次要结局
- 28-day all-cause mortality(28-day)
- 90-day all-cause mortality(90-day)
- Cardiac adverse events(In hospital, until the patient is discharged.)
- LVEF(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- APACHE II(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- Hypersensitive troponin T(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- MB(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- NT-Pro BNP(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- LDH(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- α-HBDH(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- CK(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- CKMB(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
- Lac(On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart FailureCongestive Heart FailureNCT00160134Solvay Pharmaceuticals
已完成
不适用
Safety and Effectiveness Study of the Solysafe Septal OccluderAtrial Septal DefectsNCT00353509Carag AG
已完成
2 期
Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial InfarctionFocus of Study is STEMINCT01977755Zealand Pharma591
招募中
4 期
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.MyocarditisNCT05295290Pfizer300
已完成
不适用
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac RepairHeart DiseasesNCT03176225LeMaitre Vascular142