Arterial ThrombosisTAMICINCT02896530
Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review
An observational study of Arterial Thrombosis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arterial Thrombosis
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Jun 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with arterial Thrombosis and Inflammatory Bowel Disease
Who may be able to join
- Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the 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
- Conditions
- Arterial Thrombosis
- Being tested
- No intervention. Description study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Description studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of the number of thromboembolic events or venous or arterial
Measured: Month 6, year 2
Secondary outcomes (1)
Assessment of the relevance of anti thrombosis treatment
Is the anti thrombosis treatment adequate or have been changed during the monitoring? The answer to this question should be :yes or no
Measured: Month 6, year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial ThrombosisStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896530
- Sponsor's protocol ID
- TAMICI
- Acronym
- TAMICI
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review
- ClinicalTrials.gov ID
- NCT02896530
- Acronym / sponsor ID
- TAMICI / TAMICI
- Conditions
- Arterial Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Sep 2016 (estimated)
- 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.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with arterial Thrombosis and Inflammatory Bowel Disease
Key inclusion criteria (1 listed)
- Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. Description study | Other | – |
Primary outcome
Assessment of change of the number of thromboembolic events or venous or arterial
Time frame: Month 6, year 2
1 secondary outcome
Assessment of the relevance of anti thrombosis treatment
Time frame: Month 6, year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Thrombosis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of the number of thromboembolic events or venous or arterial (time frame: Month 6, year 2). 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 12 Sep 2016.