Trial document





This trial has been registered retrospectively.
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  DRKS00005642

Trial Description

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Title

Pulse wave velocity and intima-media thickness as an indication of cardiovascular degeneration in patients after chemotherapy in childhood and adolescence.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Children who have had chemotherapy for their oncological diseases may have suffered cardiovascular damage.
It is now examined by comparison with age-appropriate norms of non-affected children and adolescents, whether PWG and IMT are changed and thus there is a vascular damage.
The early discovery of microangiopathies in children and adolescents is crucial, as the damage caused by changes in lifestyle or medication in this period of life in principle reversible. By early intervention, children exposed to chemotherapy, e.g. protected from overt hypertension in adulthood.

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Organizational Data

  •   DRKS00005642
  •   2018/01/08
  •   [---]*
  •   yes
  •   Approved
  •   2015-73, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C40 -  Malignant neoplasm of bone and articular cartilage of limbs
  •   C41 -  Malignant neoplasm of bone and articular cartilage of other and unspecified sites
  •   C47 -  Malignant neoplasm of peripheral nerves and autonomic nervous system
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
  •   C65 -  Malignant neoplasm of renal pelvis
  •   C71 -  Malignant neoplasm of brain
  •   C74 -  Malignant neoplasm of adrenal gland
  •   C81 -  Hodgkin lymphoma
  •   C83 -  Non-follicular lymphoma
  •   C84 -  Mature T/NK-cell lymphomas
  •   C85.9 -  Non-Hodgkin lymphoma, unspecified
  •   C86 -  Other specified types of T/NK-cell lymphoma
  •   C91 -  Lymphoid leukaemia
  •   C92 -  Myeloid leukaemia
  •   C93 -  Monocytic leukaemia
  •   C95 -  Leukaemia of unspecified cell type
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Interventions/Observational Groups

  •   Patients included during the regular cardiac check will receive a history, physical examination, ECG, echocardiography, sonographic intima-media thickness measurement on the carotid and a long-term 24h blood pressure measurement with pulse wave analysis. All data are logged pseudonymised.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Pulse wave speed: When lying down, after a rest period of five minutes, the standardized system of the Mobil-O-Graphen® PWA (I.E.M., Stolberg, Germany) takes place on the left upper arm.

Intima-media thickness:
Intima-media thickness at the common carotid artery (ACC) with a linear sound head (IPx-7 L12-5 50, 12-5 MHz, Philipps) and the preset thyroid (24-42Hz) according to the "leading-edge" method trained doctor or doctoral student.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/24
  •   110
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   31   Years
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Additional Inclusion Criteria

All patients in the pediatric cardiology department of the MLU who are cared for in one year between the ages of 1-31 years with a condition after cardiotoxic therapy in the context of an oncological disease in children and adolescents. The primary chemotherapy of these patients is more than a year and the last chemotherapy is more than two months ago.

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Exclusion Criteria

Patients whose primary chemotherapy is less than one year and whose last chemotherapy is less than two months old or who do not meet the inclusion criteria.

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Addresses

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    • Universistätsklinikum Halle
    • Mr.  Prof. Dr.  Ralph  Grabitz 
    • Ernst-Grube Straße 40
    • 06120  Halle
    • Germany
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    • Universitätsklinikum Halle (Saale), Kinderkardiologische Ambulanz
    • Mr.  Prof. Dr.  Ralph  Grabitz 
    • Ernst-Grube Straße 40
    • 06120  Halle
    • Germany
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    • Universitätsklinikum Halle
    • Mr.  Chirstian  Dubau 
    • Ernst-Grube Straße 40
    • 06120  Halle
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Halle (Saale)Kinderkardiologische Ambulanz
    • Ernst-Grube Straße 40
    • 06120  Halle
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/08/15
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Trial Publications, Results and other Documents

  •   Ethikvotum
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