TAMICI: Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review

• Sponsor: Groupe Hospitalier Paris Saint Joseph (Other)
• Overall Status: Completed
• CT.gov ID: NCT02896530
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

Condition or Disease	Intervention/Treatment	Phase
Arterial Thrombosis	Other: No intervention. Description study

Detailed Description

Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

However, the association between IBD and arterial thromboembolic events such as cases of myocardial infarction, stroke, aortic thrombus, mesenteric ischemia, peripheral arterial disease and members senior, was described less and remains a subject of debate. These arterial complications occur in young subjects accountability of IBD remains debated, and no clear pathophysiology. Here the investigators describe a series of 6 cases of patients with IBD who developed severe arterial complications, and whose cause was retained digestive inflammatory underlying disease.

This study is report of six (6) cases that will be described

Study Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Outcome Measures

Primary Outcome Measures

1. Assessment of change of the number of thromboembolic events or venous or arterial [Month 6, year 2]

Secondary Outcome Measures

1. Assessment of the relevance of anti thrombosis treatment [Month 6, year 2]

   Is the anti thrombosis treatment adequate or have been changed during the monitoring? The answer to this question should be :yes or no

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital

Exclusion Criteria:

• No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France	France	75014

Sponsors and Collaborators

• Groupe Hospitalier Paris Saint Joseph

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier Paris Saint Joseph
• ClinicalTrials.gov Identifier: NCT02896530
• Other Study ID Numbers: TAMICI
• First Posted: Sep 12, 2016
• Last Update Posted: Sep 12, 2016
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Inflammatory Bowel Diseases; Thrombosis

Study Results

No Results Posted as of Sep 12, 2016