Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

RWTH Aachen University

Status

Unknown

Conditions

Cardiac Insufficiency

Treatments

Other: blood withdrawal

Study type

Observational

Funder types

Other

Identifiers

NCT03648736

17-164

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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