EUCTR2014-004512-11-ES进行中（未招募）不适用
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of vitamin D on ventricular remodeling in patients with acute myocardial infarction: Test VITDAMI (Vitamin D in Acute Myocardial Infarction) - VITDAMI Clinical Trial (Vitamin D in Acute Myocardial Infarction)
INSTITUTO DE INVESTIGACION SANITARIA FJD0 个研究点开始时间: 2015年4月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Age between 40 and 85 years.
- •2. Be ready to be discharged after STEMI previous location which is complete revascularization and defined as suggestive symptoms such as chest tightness, in the arms or jaw, or simply supported as sweating, nausea, vomiting and malaise bad defined longer than 20 minutes with ST-segment elevation in the ECG of 0.2 mV in ?2 contiguous precordial leads unresponsive to nitroglycerin followed Troponin I> 0.12 with a standard curve.
- •3. Acceptance and signing the consent for the study after receiving adequate information.
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •11. Death during the index event
- •2. Age younger than 40 or older than 85 years
- •3. Complications prolong their stay more than 7 days in the index event.
- •4. Infarct-s-s prior infarction.
- •5. Disease limiting survival
- •6. Systemic inflammatory disease or autoimmune
- •7. concomitant restrictive cardiomyopathy, dilated or hypertrophic.
- •8. severe ventricular hypertrophy of any etiology defined as ?17 mm wall thickness ?16 mm in men and women
- •9. renal glomerular filtration lower estimate of 45 ml / min / 1.73 m2 by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration)
- •10. The need for heart transplantation
- •11. ejection fraction less than 30%
- •12. Failure to perform the desirable revascularization
- •13. Revascularization pending at the time of discharge
- •14. valvular prosthesis
- •15. Aortic stenosis with average gradient> 25 mm Hg (Doppler) and any other valve stenosis.
- •16. moderate or severe valvular insufficiency at any level
- •17. Hypersensitivity or intolerance vitamin D supplement to employ or to any of the excipients.
- •18. Indication of treatment with vitamin D and / or calcium supplements or patient decision making these compounds in the absence of clinical indication.
- •19. Concomitant therapy with drugs that could interfere with calcifediol pK-pD.
- •20. Concomitant diseases that could interfere with calcifediol pK-pD
- •21. Calcium> 10.5 mg / dl, history of hypercalciuria or calcium stones
- •22. Contraindications to MRI: Claustrophobia, pacemaker, defibrillator and / or resynchronization, or are anticipated to need during the study.
- •23. Inability to follow.
- •24. Difficulty to meet the study treatment as determined by your doctor
- •25. Patient refusal to participate and signed informed consent.
- •26. Pregnancy or breast-feeding state.
研究者
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