Trial document




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  DRKS00017481

Trial Description

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Title

Registry for CRP apheresis after acute myocardial infarction

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Trial Acronym

CAMI-Registry

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URL of the Trial

http:///

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Brief Summary in Lay Language

The prognostic value of C-reactive protein (CRP) in assessing the course of acute myocardial infarction (AMI) is well known: The higher the increase in CRP in the days following the infarction, the worse the prognosis.
With CRP apheresis, the increase in CRP can be effectively limited, which can lead to an improved prognosis. CRP apheresis is a therapeutic haemapheresis procedure in which the C-reactive protein is selectively and effectively removed from the patient's plasma in an extracorporeal circuit using a regenerable adsorber. To remove the pathogenic substance, plasma is separated from a continuous blood circuit and passed through an adsorber. The purified plasma is then recombined with the solid blood components and returned to the patient. The frequency and intervals of the treatments depend on the initial CRP concentration. In addition to the immediate effects, particular interest lies in the assessment of the course of the disease in the first 30 days and 12 months after the infarction.
The CAMI registry is intended to map the course of the disease and the examination/treatment, especially of AMI patients following guideline-based primary therapy, for whom elevated CRP values were measured (target population).
The pseudonymised data will be used to extend the experience on the clinical efficiency of CRP apheresis, to optimise the quality of the therapeutic application and to identify possible treatment or device-associated complications as early as possible.
All relevant information such as diagnosis, concomitant diseases, therapeutic measures, medication, disease status and clinical laboratory parameters on the course of treatment are documented in the registry.
The data collected are regularly evaluated and published.
The CAMI registry is an effective tool to create the data basis for justifying and optimising medical decisions. The heterogeneity of the patient group also makes it possible to identify subgroups whose risk-benefit profile can be evaluated in a differentiated manner.

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Brief Summary in Scientific Language

The CAMI registry is carried out multicentrally as a non-interventional study (NIS).
It offers the possibility to systematically record a new treatment option, the CRP apheresis, for the targeted reduction of CRP level after guideline-based primary treatment of acute myocardial infarction. In CRP apheresis, CRP is selectively removed from the plasma in an extracorporeal circuit using an adsorber. The number of treatments depends on the level of the CRP concentration. Usually 2-3 treatments are carried out, each of which processing 1.5 - 2.5 times the plasma volume.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00017481
  •   2019/06/28
  •   [---]*
  •   no
  •   Approved
  •   19004, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   U1111-1234-9723 
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Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
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Interventions/Observational Groups

  •   Patients with elevated CRP levels following guideline-based primary treatment of acute myocardial infarction may be treated with the CRP apheresis as a new treatment option for the targeted reduction of the CRP concentration.
    The CAMI registry is intended to document the course of the disease and the examination/treatment of these patients in particular. All relevant information such as diagnosis, concomitant diseases, therapeutic measures, medication, disease status as well as clinical laboratory parameters over the course of treatment will be recorded. In addition, the evaluation of the course of the disease in the first 30 days and 12 months after the infarct is of particular interest.
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Characteristics

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

Occurrence of cardiac events 30 days and 12 months after acute myocardial infarction

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Secondary Outcome

Heart pumping capacity (left ventricular ejection fraction, LVEF),
Myocardial tissue damage in neuroimaging procedures,
occurrence of undesirable effects of CRP apheresis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/06/25
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Acute myocardial infarction after guideline primary treatment, elevated CRP concentration, CRP-apheresis

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Exclusion Criteria

None

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Addresses

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Mr.  Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Sources of Monetary or Material Support

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.