NL-OMON47742已完成2 期
Groningen Intervention study for the Preservation of cardiac function with sodium thiosulfate after ST-segment elevation myocardial infarction - GIPS-IV
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Age * 18 years;, 2. The diagnosis STEMI defined by (1) chest pain suggestive
- •for myocardial ischemia for at least 30 minutes, the time from onset of the
- •symptoms less than 12 hours before hospital admission, and (2) an
- •electrocardiogram recording with ST- segment elevation of more than 0.1 mV in 2
- •or more contiguous leads or presence of new left bundle branch block;;, 3.
- •Symptoms and/or ST-segment deviation should be present (persisting) at time of
- •arrival in the catheterization laboratory;, 4. Primary percutaneous
- •intervention is being considered as treatment;, 5. Patient is willing to
- •cooperate with follow-up during 2 years.
排除标准
- •1. Prior myocardial infarction, unless maximum troponin T< 50 ng/L
- •(STEMI/non-STEMI/acute coronary syndrome);
- •2. Known permanent atrial fibrillation;
- •3. Prior CABG;
- •4. Prior PCI, complicated by periprocedural infarction, unless maximum troponin
- •T < 50ng/L;
- •5. Known cardiomyopathy;
- •6. Previous hospitalization for heart failure
- •7. Active malignancy (requiring chemotherapy, radiation or surgery at the time
- •of randomization), except for adequately treated non-melanoma skin cancer or
- •other noninvasive or in situ neoplasm (e.g., cervical cancer in situ);
- •8. History of chemotherapy;
- •9. History of radiotherapy in chest region;
- •10. Relieve of symptoms and complete ST-segment resolution prior to arrival at
- •the catheterization laboratory;
- •11. Presentation with cardiogenic shock (systolic blood pressure < 90 mmHg);
- •12. Severe hypertension (systolic blood pressure > 220 mmHg);
- •13. Sedated and/or intubated patients;
- •14. The existence of a condition with a life expectancy of less than 1 year;
- •15. Contraindication for 3 Tesla (T) CMR-imaging (e.g. body weight >;150kg;
- •known claustrophobia; 3T MRI incompatible ferromagnetic objects in the body,
- •end-stage renal disease);
- •16. Pregnancy or breastfeeding women; women of childbearing potential with
- •clinical suspicion of possible pregnancy;
- •17. A condition which, according to the clinical judgment of the investigator
- •and/or treating physician, does not allow the patient to successfully
- •participate in the study.
研究者
相似试验
进行中（未招募）
1 期
Groningen intervention study for the protection of heart function after a heart attackST-segment elevated myocardial infarction, decompensatio cordisEUCTR2015-001006-34-NLniversity Medical Centre Groningen (UMCG)380
已完成
不适用
A preliminary study to evaluate the preservation effects on renal functioJPRN-UMIN000035060Soiken Inc.550
已完成
不适用
Evaluation of intervention program for maintaining and rejuvenating an organization of health promotion volunteerHealth promotion volunteersJPRN-UMIN000008513Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology500
尚未招募
不适用
Cervical cancer screening using Smart Scope in primary health centersCTRI/2022/10/046849Periwinkle Technologies Pvt Limited
已完成
不适用
Development and evaluation of the intervention program on improving work-life balance for working parents with pre-school child(ren): randomized control trial (multi-institutional joint research)Working parents with pre-school child(ren)JPRN-UMIN000034201Faculty of Policy Management, Keio University1,120