Time Course of Circulating Myocardial Biomarkers After a TASH Procedure. (TASH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03648736|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment|
|Cardiac Insufficiency||Other: blood withdrawal|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
selected for routine TASH procedure
Other: blood withdrawal
- Time course of FGF23 (c-terminal) [ Time Frame: 1 month ]from baseline to 4 weeks after TASH procedure
- Time course of FGF23 (intact) [ Time Frame: 1 month ]from baseline to 4 weeks after TASH procedure
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648736
|Contact: Robert Stöhr, Dr.||+49 241 80 email@example.com|
|Aachen University Hospital; Medical Clinic I - Cardiology, Pneumology, Angiology and Internal Intensive Medicine||Recruiting|
|Aachen, NRW, Germany, D-52074|
|Contact: Robert Stöhr, Dr. med. +49 241 80 36351 firstname.lastname@example.org|
|Principal Investigator:||Robert Stöhr, Dr. med.||RWTH Aachen University, Aachen University Hospital, Medical Clinic I|