Time Course of Circulating Myocardial Biomarkers After a TASH Procedure. (TASH)
2020年3月10日 更新者：RWTH Aachen University
The study evaluates the released myocardial substances in blood of HOCM patients after TASH procedure (small "controlled" myocardial infarction).
This helps to identify new pathomechanisms and biomarker and thus provides a better understanding of development and progress of cardiac insufficiency.
研究概览
详细说明
All patients who receive a TASH procedure in the Medical Clinic I routinely receive routinely implementation of arterial pressure catheter for invasive blood pressure monitoring (usually Arteria radialis) as well as a central venous catheter. Directly after the procedure, the blood is taken through the central venous catheter. The operation is then terminated as planned.
The postoperative treatment is performed according to the Standard Operating Procedures (SOPs) of the Medical clinic I -regular blood sampling is performed to monitor the patient's cardiac, renal and hepatic lab values. The patient is released on the 3-5th post-operative day.
As part of a routine outpatient visit to the Medical Clinic I 1 week and 1 month after the TASH procedure, an anamnestic record as well as a blood analysis is made. One month after the TASH procedure, an echocardiographic follow-up of the HOCM is routinely performed.
Adverse events or serious adverse events are documented, assessed and reported in accordance with GCP (good clinical practice).
研究类型
观察性的
注册 (预期的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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NRW
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Aachen、NRW、德国、D-52074
- 招聘中
- Aachen University Hospital; Medical Clinic I - Cardiology, Pneumology, Angiology and Internal Intensive Medicine
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接触：
- Robert Stöhr, Dr. med.
- 电话号码：+49 241 80 36351
- 邮箱：rstoehr@ukaachen.de
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
HOCM patients selected for routine TASH procedure
描述
Inclusion Criteria:
- a clinical indication for TASH procedure
- an access to blood vessels
- a person qualified for legal acts, mentally abte to follow the instructions of study stuff
Exclusion Criteria:
- patients with severe anaemia - Hb <8 mg/dL
- patients with acute infectious diseases (e.g. pneumonia)
- patients with acute myocardial ischaemia (e.g. angina pectoris or ECG alterations under strain)
- patients with acute coronary syndrome in the last three months
- patients that were hospitalized for Acute Heart Failure during the last month and had to be treated by diuretics or inotropes
- a pregnant and/or breastfeeding women
- Persons that are located by a court or administrative decision in an Institution
- Persons with a relationship of dependency to investigator
- Persons with simultaneous participation in another clinical trial
- administration of an investigational drug 30 days before start of the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
HOCM patients
selected for routine TASH procedure
|
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time course of FGF23 (c-terminal)
大体时间：1 month
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from baseline to 4 weeks after TASH procedure
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1 month
|
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Time course of FGF23 (intact)
大体时间：1 month
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from baseline to 4 weeks after TASH procedure
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1 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Robert Stöhr, Dr. med.、RWTH Aachen University, Aachen University Hospital, Medical Clinic I
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Faul C, Amaral AP, Oskouei B, Hu MC, Sloan A, Isakova T, Gutierrez OM, Aguillon-Prada R, Lincoln J, Hare JM, Mundel P, Morales A, Scialla J, Fischer M, Soliman EZ, Chen J, Go AS, Rosas SE, Nessel L, Townsend RR, Feldman HI, St John Sutton M, Ojo A, Gadegbeku C, Di Marco GS, Reuter S, Kentrup D, Tiemann K, Brand M, Hill JA, Moe OW, Kuro-O M, Kusek JW, Keane MG, Wolf M. FGF23 induces left ventricular hypertrophy. J Clin Invest. 2011 Nov;121(11):4393-408. doi: 10.1172/JCI46122. Epub 2011 Oct 10.
- Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. doi: 10.1056/NEJMra021498. No abstract available.
- Jessup M, Brozena SC. Epilogue: support devices for end stage heart failure. Cardiol Clin. 2003 Feb;21(1):135-9. doi: 10.1016/s0733-8651(02)00139-x.
- Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011 Jan;8(1):30-41. doi: 10.1038/nrcardio.2010.165. Epub 2010 Nov 9.
- Kenchaiah S, Narula J, Vasan RS. Risk factors for heart failure. Med Clin North Am. 2004 Sep;88(5):1145-72. doi: 10.1016/j.mcna.2004.04.016.
- Leifheit-Nestler M, Grosse Siemer R, Flasbart K, Richter B, Kirchhoff F, Ziegler WH, Klintschar M, Becker JU, Erbersdobler A, Aufricht C, Seeman T, Fischer DC, Faul C, Haffner D. Induction of cardiac FGF23/FGFR4 expression is associated with left ventricular hypertrophy in patients with chronic kidney disease. Nephrol Dial Transplant. 2016 Jul;31(7):1088-99. doi: 10.1093/ndt/gfv421. Epub 2015 Dec 17.
- Mirza MA, Larsson A, Melhus H, Lind L, Larsson TE. Serum intact FGF23 associate with left ventricular mass, hypertrophy and geometry in an elderly population. Atherosclerosis. 2009 Dec;207(2):546-51. doi: 10.1016/j.atherosclerosis.2009.05.013. Epub 2009 May 21.
- Andrukhova O, Slavic S, Odorfer KI, Erben RG. Experimental Myocardial Infarction Upregulates Circulating Fibroblast Growth Factor-23. J Bone Miner Res. 2015 Oct;30(10):1831-9. doi: 10.1002/jbmr.2527. Epub 2015 May 6.
- Andersen IA, Huntley BK, Sandberg SS, Heublein DM, Burnett JC Jr. Elevation of circulating but not myocardial FGF23 in human acute decompensated heart failure. Nephrol Dial Transplant. 2016 May;31(5):767-72. doi: 10.1093/ndt/gfv398. Epub 2015 Dec 13.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月10日
初级完成 (预期的)
2021年5月1日
研究完成 (预期的)
2021年5月1日
研究注册日期
首次提交
2018年8月22日
首先提交符合 QC 标准的
2018年8月24日
首次发布 (实际的)
2018年8月27日
研究记录更新
最后更新发布 (实际的)
2020年3月12日
上次提交的符合 QC 标准的更新
2020年3月10日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The results of the study will be published in a scientific paper.
The Ethics Committee will be informed about the results of the study.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
心功能不全的临床试验
blood withdrawal的临床试验
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Stefan LakämperUniversity Hospital, Zürich招聘中阻塞性睡眠呼吸暂停 (OSA) | 驾驶障碍 | 呼吸机 | 白天过度嗜睡 | 驾驶模拟器性能 | 持续气道正压通气治疗瑞士