Predictors of Subclinical Atherosclerotic Cardiovascular Diseases (ASCVD) in Patients With Inflammatory Bowel Disease

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases

Detailed Description

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)

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Hussien Ahmed EL-Amen, MD; Phone Number: 0201004084187; Email: drmaam2007@gmail.com
• Study Contact Backup: Name: Soheir Mustafa Kassem, MD; Phone Number: 01069347314; Email: soheir1980@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
inflammatory bowel diease patients
normal indivuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
atherosclerotic effects in patients with inflammatory bowel disease	hypertension and ischemic heart disease	two years duration

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Hussien Ahmed EL-Amen, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 20, 2019
• Primary Completion (Anticipated): March 20, 2021
• Study Completion (Anticipated): March 20, 2021

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Gastrointestinal Diseases; Gastroenteritis; Cardiovascular Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Atherosclerosis
• Other Study ID Numbers: posacvdpwibd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No