Inflammatory Bowel DiseasesNCT03868332
Predictors of Subclinical Atherosclerotic Cardiovascular Diseases (ASCVD) in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2019to 20 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Previous history of hypertension , diabetes mellitus, Dyslipidemia
- Previous history of cardiovascular or cerebrovascular events
- Autoimmune , Neoplastic diseases
- Thromboembolic diseases
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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)
- Conditions
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| inflammatory bowel diease patients | Not described | |
| normal indivuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
atherosclerotic effects in patients with inflammatory bowel disease
hypertension and ischemic heart disease
Measured: two years duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start20 Jul 2019 (estimated)
- Primary completion20 Mar 2021 (estimated)
- Study completion20 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar ahmed ammar, Assiut University
- Investigators
- Hussien Ahmed EL-Amen, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868332
- Sponsor's protocol ID
- posacvdpwibd
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Subclinical Atherosclerotic Cardiovascular Diseases (ASCVD) in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03868332
- Acronym / sponsor ID
- posacvdpwibd
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2019 (estimated)
- Primary completion
- 20 Mar 2021 (estimated)
- Study completion
- 20 Mar 2021 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inflammatory bowel diease patients | – | – |
| normal indivuals | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Previous history of hypertension , diabetes mellitus, Dyslipidemia
- Previous history of cardiovascular or cerebrovascular events
- Autoimmune , Neoplastic diseases
- Thromboembolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
atherosclerotic effects in patients with inflammatory bowel disease
Time frame: two years duration
hypertension and ischemic heart disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussien Ahmed EL-Amen, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussien Ahmed EL-Amen, MD (0201004084187, drmaam2007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atherosclerotic effects in patients with inflammatory bowel disease (time frame: two years duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.