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the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Sjogren Syndrome Patients (HAS)

2 de março de 2015 atualizado por: yair levy, Meir Medical Center

Retrospective Study That Evaluate the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Patients With Primary Sjogren Syndrome

sjogren syndrome is an autoimmune disease that mainly affects the Salivary glands and Lacrimal gland In addition to the effects of this disease is characterized by overall systemic Muskals injury, pulmonary disease, peripheral neuropathy and vasculitis. In addition recent studies have shown that patients are at increased risk of the disease up to 2 cardiac events and stroke events Hydroxychloroquine is an RHEUMATIC DISEASE PROCESS SUPPRESSANTS-ANTIMALARIALS used to treat anti-inflammatory rheumatic diseases in many first-line treatment is sjogren syndrome.

A recent study of the treatment in Hydroxychloroquine effect on lipid profile sjogren syndrome patients showed a reduction in total cholesterol levels and increase in HDL. Further studies of the impact made Hydroxychloroquine systemic lupus patients erythematosus (SLE) showed in Atherosclerosis and morbidity and mortality reduction in cardiovascular. Studies of patients with rheumatoid arthritis (RA) demonstrated reduced risk of developing diabetes and improved lipid profile Research Goals valuate The effect of HCQ treatment in cardiovascular patients with primary sjogren syndrome

Visão geral do estudo

Status

Desconhecido

Condições

Primary Sjogren Syndrome With Multisystem Involvement

Intervenção / Tratamento

Outro: Retrospective study

Descrição detalhada

Research Goals Valuate The effect of HCQ treatment in cardiovascular patients with primary sjogren syndrome Research Methods The study will included patients that diagnosed with sjogren syndrome and was treated in Meir Medical center during the years 2003-2014 During the study will collect information on confounding factors , Risk factors include cardiovascular acceptable such as diabetes, dyslipidemia, high blood pressure and the like, central nervous system involvement and steroid use

Study outcome will be one of the follow:

Thrombosis of peripheral veins
Arterial cardiovascular events
Cardiac events (myocardial infarction
Stroke (stroke and TIA)

4. Venous thrombosis events 5. Pulmonary embolism In the study will be 500 patients

Inclusion criteria:

18 years old
Both sexes
Patients that diagnosis in sjogren in treated in Meir Medical center in the years 2003-2014 And treated in Hydroxychloroquine at least a month.

Exclusion criteria:

Minors and special populations
Patients that treated in Hydroxychloroquine at less than a month.
Patient that participate in clinical trial and treat with investigational product

Tipo de estudo

Observacional

Inscrição (Antecipado)

500

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients that diagnosis in sjogren in treated in Meir Medical center

Descrição

Inclusion Criteria:

18 years old
Both sexes
Patients that diagnosis in sjogren in treated in Meir Medical center in the years 2003-2014 And treated in Hydroxychloroquine at least a month.

Exclusion Criteria:

Minors and special populations
Patients that treated in Hydroxychloroquine at less than a month.
Patient that participate in clinical trial and treat with investigational product

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Prazo
Arterial cardiovascular events Prazo: 15 years since the first dose of hydroxychloroquine	15 years since the first dose of hydroxychloroquine

Medidas de resultados secundários

Medida de resultado	Prazo
Cardiac events (myocardial infarction Prazo: 15 years since the first dose of hydroxychloroquine	15 years since the first dose of hydroxychloroquine
Thrombosis of peripheral veins Prazo: 15 years since the first dose of hydroxychloroquine	15 years since the first dose of hydroxychloroquine
Stroke (stroke and TIA) Prazo: 15 years since the first dose of hydroxychloroquine	15 years since the first dose of hydroxychloroquine
Venous thrombosis events Prazo: 15 years since the first dose of hydroxychloroquine	15 years since the first dose of hydroxychloroquine
Pulmonary embolism Prazo: 15 years since the first dose of hydroxychloroquine	15 years since the first dose of hydroxychloroquine

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Meir Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2015

Conclusão Primária (Antecipado)

1 de abril de 2016

Conclusão do estudo (Antecipado)