- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02381587
the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Sjogren Syndrome Patients (HAS)
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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Arterial cardiovascular events
Lasso di tempo: 15 years since the first dose of hydroxychloroquine
|
15 years since the first dose of hydroxychloroquine
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Cardiac events (myocardial infarction
Lasso di tempo: 15 years since the first dose of hydroxychloroquine
|
15 years since the first dose of hydroxychloroquine
|
Thrombosis of peripheral veins
Lasso di tempo: 15 years since the first dose of hydroxychloroquine
|
15 years since the first dose of hydroxychloroquine
|
Stroke (stroke and TIA)
Lasso di tempo: 15 years since the first dose of hydroxychloroquine
|
15 years since the first dose of hydroxychloroquine
|
Venous thrombosis events
Lasso di tempo: 15 years since the first dose of hydroxychloroquine
|
15 years since the first dose of hydroxychloroquine
|
Pulmonary embolism
Lasso di tempo: 15 years since the first dose of hydroxychloroquine
|
15 years since the first dose of hydroxychloroquine
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie degli occhi
- Patologia
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Artrite
- Malattie stomatognatiche
- Malattie della bocca
- Malattie dell'apparato lacrimale
- Artrite, reumatoide
- Xerostomia
- Malattie delle ghiandole salivari
- Sindromi dell'occhio secco
- Malattia cardiovascolare
- Sindrome
- Sindrome di Sjogren
Altri numeri di identificazione dello studio
- HCQ and sjogren
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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