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- Essai clinique NCT03868332
Predictors of Subclinical Atherosclerotic Cardiovascular Diseases (ASCVD) in Patients With Inflammatory Bowel Disease
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Heart disease and failure are the major causes of mortality and morbidity worldwide, despite significant advances in medical technologies in the diagnosis and treatment of the disease. Cardiovascular disease may arise for various reasons including the steadily increasing incidence of obesity, type 2 diabetes, genetic, environmental, dietary and lifestyle factors. Besides all these, there is much evidence suggetsing that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis(1,2). Clinically, patients with rheumatologic diseases have been found to suffer from coronary heart disease; thus, regular monitoring for Cardiovascular disease should be included as a routine assessment for patients with rheumatologic diseases (3). A most common systemic inflammatory disease is inflammatory bowel disease , which is a collection of ulcerative colitis and Crohn's disease, a chronic intestinal disease that may arise due to different factors, and is precipitated by environmental and genetic susceptibility (4,5). Ulcerative colitis and Crohn's disease are characterized by chronic intestinal inflammation, with gastrointestinal symptoms including diarrhea, blood and pus in stools, abdominal pain, fever and weight loss. The incidence of inflammatory bowel disease is on the increase in Canada (6), Europe (7) and Asia (8
). In ulcerative colitis, inflammation is mostly limited to mucosal layer of the colon and involves rectum and other parts of colon (9). On the other hand, Crohn's disease shows characteristic transmural inflammation and fibrosis and occurs as patchy lesions throughout the gastrointestinal tract (10).
Although inflammatory bowel disease is associated with venous vascular problems such as deep venous thrombosis (11), the extent of risk for the patients with inflammatory bowel disease to develop Cardiovascular disease, in particular coronary artery disease is not well understood. inflammatory bowel disease patients have a 2 to 3-fold higher risk of venous thromboembolism than the general population (12), and this risk is high during acute disease flare, as active inflammation tilts the balance between pro-coagulants and anticoagulants, which leads to the characteristic hypofibrinolysis seen in inflammatory bowel disease (13)
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
population of the study will be classified into two groups, one with inflammatory bowel disease ,other is healthy volunteers.
both groups will be investigated for early cardiovascular atherosclerotic changes.
La description
Inclusion Criteria:
Patients who are diagnosed as ulcerative colitis / Crhon s disease however in activity or in remission attending the the outpatient clinics and inpatient of gastroenterology units of Internal medicine department
Exclusion Criteria:
- Previous history of hypertension , diabetes mellitus, Dyslipidemia
- Previous history of cardiovascular or cerebrovascular events
- Autoimmune , Neoplastic diseases
- Thromboembolic diseases
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
inflammatory bowel diease patients
|
normal indivuals
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
atherosclerotic effects in patients with inflammatory bowel disease
Délai: two years duration
|
hypertension and ischemic heart disease
|
two years duration
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Hussien Ahmed EL-Amen, MD, Assiut University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- posacvdpwibd
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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