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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648736
Recruitment Status : Unknown
Verified March 2020 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : August 27, 2018
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Insufficiency Other: blood withdrawal

Detailed Description:

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort Intervention/treatment
HOCM patients
selected for routine TASH procedure
 Other: blood withdrawal
  • peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure
  • central-venous during TASH


Outcome Measures
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Primary Outcome Measures :
  1. Time course of FGF23 (c-terminal) [ Time Frame: 1 month ]
    from baseline to 4 weeks after TASH procedure

  2. Time course of FGF23 (intact) [ Time Frame: 1 month ]
    from baseline to 4 weeks after TASH procedure


Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HOCM patients selected for routine TASH procedure
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Robert Stöhr, Dr. +49 241 80 36351 rstoehr@ukaachen.de

Locations
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Germany
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    rstoehr@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Robert Stöhr, Dr. med. RWTH Aachen University, Aachen University Hospital, Medical Clinic I
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03648736    
Other Study ID Numbers: 17-164
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The results of the study will be published in a scientific paper. The Ethics Committee will be informed about the results of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
FGF23, TASH
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases