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Blueprint for a European calciphylaxis registry initiative: the European Calciphylaxis Network (EuCalNet).

Brandenburg V, Adragao T, van Dam B, Evenepoel P, Frazão JM, Ketteler M, Mazzaferro S, Urena Torres P, Ramos R, Torregrosa JV, Cozzolino M - Clin Kidney J (2015)

Bottom Line: The epidemiology and risk factors associated with this disease are still not fully understood.Moreover, CUA treatment strategies vary significantly among centres and expert recommendations are heterogeneous.The registry includes a comprehensive database with questions covering >70 parameters and items regarding patient-related and laboratory data, clinical background and presentation as well as therapeutic strategies.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology , University Hospital RWTH Aachen , Aachen , Germany; on behalf of the ERA-EDTA scientific working group 'CKD-MBD'

ABSTRACT
Calcific uraemic arteriolopathy (CUA) is a rare disease and continues to be a clinical challenge. The typical course of CUA is characterized by painful skin discolouration and induration evolving to necrotic ulcerations. Medial calcification of cutaneous arterioles and extensive extracellular matrix remodelling are the hallmarks of CUA. The epidemiology and risk factors associated with this disease are still not fully understood. Moreover, CUA treatment strategies vary significantly among centres and expert recommendations are heterogeneous. Registries may provide important insights and information to increase our knowledge about epidemiology and clinical aspects of CUA and may help to optimize its therapeutic management. In 2006, we established an internet-based registry in Germany (www.calciphylaxie.de) to allow online notification of patients with established or suspected CUA. The registry includes a comprehensive database with questions covering >70 parameters and items regarding patient-related and laboratory data, clinical background and presentation as well as therapeutic strategies. The next phase will be to allow international patient registration via www.calciphylaxis.net as part of the multinational EuCalNet (European Calciphylaxis Network) initiative, which is supported by the ERA-EDTA scientific working group 'CKD-MBD'. Based on the valuable experience with the previous German CUA registry, EuCalNet will be a useful tool to collect data on the rare disease CUA and may become a basis for prospective controlled trials in the near future.

No MeSH data available.


Related in: MedlinePlus

Local study centres collect and administrate cases from their country. A central study centre reviews and consolidates all collected data.
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SFV056F1: Local study centres collect and administrate cases from their country. A central study centre reviews and consolidates all collected data.

Mentions: After online notification via www.calciphylaxis.net, a central processing of data will be undertaken on local country-specific levels (first level). Depending on country-specific conditions, the study centre University Hospital Aachen (second level) will assist first-level institutions regarding control of completeness and plausibility of data and also organize expert exchange regarding confirmation of diagnosis CUA. The primary contact between treating physician and peripheral centre will be established on a country level to the local principal investigator (PI). Second-level data management and final analysis is planned to be performed based on the central databank (see Figure 1). Details regarding data management and storage conditions within the biobank may vary according to local data safety restrictions and ethical committee voting. In terms of obtaining positive ethical committee voting, the EuCalNet partners will face divergent country-specific prerequisites regarding authorization of trial sites and physicians. For example, some countries will require such trial site authorization prior to notification of a patient to the registry.Fig. 1.


Blueprint for a European calciphylaxis registry initiative: the European Calciphylaxis Network (EuCalNet).

Brandenburg V, Adragao T, van Dam B, Evenepoel P, Frazão JM, Ketteler M, Mazzaferro S, Urena Torres P, Ramos R, Torregrosa JV, Cozzolino M - Clin Kidney J (2015)

Local study centres collect and administrate cases from their country. A central study centre reviews and consolidates all collected data.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4581376&req=5

SFV056F1: Local study centres collect and administrate cases from their country. A central study centre reviews and consolidates all collected data.
Mentions: After online notification via www.calciphylaxis.net, a central processing of data will be undertaken on local country-specific levels (first level). Depending on country-specific conditions, the study centre University Hospital Aachen (second level) will assist first-level institutions regarding control of completeness and plausibility of data and also organize expert exchange regarding confirmation of diagnosis CUA. The primary contact between treating physician and peripheral centre will be established on a country level to the local principal investigator (PI). Second-level data management and final analysis is planned to be performed based on the central databank (see Figure 1). Details regarding data management and storage conditions within the biobank may vary according to local data safety restrictions and ethical committee voting. In terms of obtaining positive ethical committee voting, the EuCalNet partners will face divergent country-specific prerequisites regarding authorization of trial sites and physicians. For example, some countries will require such trial site authorization prior to notification of a patient to the registry.Fig. 1.

Bottom Line: The epidemiology and risk factors associated with this disease are still not fully understood.Moreover, CUA treatment strategies vary significantly among centres and expert recommendations are heterogeneous.The registry includes a comprehensive database with questions covering >70 parameters and items regarding patient-related and laboratory data, clinical background and presentation as well as therapeutic strategies.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology , University Hospital RWTH Aachen , Aachen , Germany; on behalf of the ERA-EDTA scientific working group 'CKD-MBD'

ABSTRACT
Calcific uraemic arteriolopathy (CUA) is a rare disease and continues to be a clinical challenge. The typical course of CUA is characterized by painful skin discolouration and induration evolving to necrotic ulcerations. Medial calcification of cutaneous arterioles and extensive extracellular matrix remodelling are the hallmarks of CUA. The epidemiology and risk factors associated with this disease are still not fully understood. Moreover, CUA treatment strategies vary significantly among centres and expert recommendations are heterogeneous. Registries may provide important insights and information to increase our knowledge about epidemiology and clinical aspects of CUA and may help to optimize its therapeutic management. In 2006, we established an internet-based registry in Germany (www.calciphylaxie.de) to allow online notification of patients with established or suspected CUA. The registry includes a comprehensive database with questions covering >70 parameters and items regarding patient-related and laboratory data, clinical background and presentation as well as therapeutic strategies. The next phase will be to allow international patient registration via www.calciphylaxis.net as part of the multinational EuCalNet (European Calciphylaxis Network) initiative, which is supported by the ERA-EDTA scientific working group 'CKD-MBD'. Based on the valuable experience with the previous German CUA registry, EuCalNet will be a useful tool to collect data on the rare disease CUA and may become a basis for prospective controlled trials in the near future.

No MeSH data available.


Related in: MedlinePlus