Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time course of FGF23 (c-terminal)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •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
排除标准
- •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
结局指标
主要结局
Time course of FGF23 (c-terminal)
时间窗: 1 month
from baseline to 4 weeks after TASH procedure
Time course of FGF23 (intact)
时间窗: 1 month
from baseline to 4 weeks after TASH procedure
次要结局
未报告次要终点