Mesenteric IschemiaSurvibaseNCT04746534
Cohort SURVI : Intestinal Ischemia and Vascular Diseases
An observational study of Mesenteric Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenteric Ischemia
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2020to 4 Jan 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: active patient file of the SURVI service
Who may be able to join
- Age > 18 years old
- IMVI including :
- acute mesenteric ischaemia defined by acute digestive distress in relation to arterial and/or venous, occlusive and/or non-occlusive splanchnic-mesenteric vascular insufficiency, in the absence of an alternative diagnosis
- Chronic mesenteric ischaemia defined by chronic digestive distress (duration of symptom evolution >30 days) related to occlusive or non- occlusive arterial or venous vascular insufficiency.
- MVI: gastrointestinal arterial or venous diseases without ischaemia (atheroma, embolism, thrombosis, dissection, mediolysis, aneurysm, dysplasia, sheathing, compression, torsion)
Who cannot join
- Left ischaemic colitis without damage to the celiac trunk and/or superior mesenteric artery
- Dissection of the abdominal aorta without intestinal ischaemia
- Portal thrombosis without extension to the superior mesenteric vein
- Portal thrombosis without extension to the superior mesenteric vein
- Traumatic rupture of the digestive arteries
- Non-injected abdominal scanner or no abdominal scanner
Show all 9Show fewer
- Patient opposition to participation in research
- Patient under guardianship / curators
- Vulnerable patient: pregnant or breastfeeding women, persons deprived of their liberty, minors, adults unable or unwilling to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Olivier CORCOS
Clichy, 92110
Olivier CORCOS, 0140875000, olivier.corcos@aphp.fr
About this study
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%.
Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors.
Read more
Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient.
The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described.
The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.
Read the detailed description
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%.
Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors.
Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient.
The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described.
The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.
- Conditions
- Mesenteric Ischemia
- Medical subject headings
- Mesenteric Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality of Intestinal Ischemia
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases (IIVD) at 1 year in terms of mortality.
Measured: 1 year
mortality of Intestinal Ischemia
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases (IIVD) at 5 years in terms of mortality.
Measured: 5 years
Vascular Diseases (IIVD)
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases
Measured: 1 year
Vascular Diseases (IIVD)
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases
Measured: 5 years
Secondary outcomes (10)
Describe the prevalence of IIVD
Measured: 1 year
Describe the prevalence of IIVD
Measured: 5 years
Study mortality and its associated factors of IIVD
Measured: 1 year
Study mortality and its associated factors of IIVD
Measured: 5 years
Study the risk of intestinal resection of IIVD and its associated factors. Among resected patients, describe the incidence of short intestinal syndrome and dependence on parenteral nutrition
Measured: 1 year
Study the risk of intestinal resection of IIVD and its associated factors. Among resected patients, describe the incidence of short intestinal syndrome and dependence on parenteral nutrition
Measured: 5 years
To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors
Measured: 1 year
To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors
Measured: 5 years
To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.
Measured: 1 year
To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start27 Nov 2020
- Primary completion4 Jan 2041 (estimated)
- Study completion4 Jan 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746534
- Sponsor's protocol ID
- APHP200184
- Acronym
- Survibase
- Status last verified
- Nov 2020
- First submitted
- 18 Dec 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort SURVI : Intestinal Ischemia and Vascular Diseases
- ClinicalTrials.gov ID
- NCT04746534
- Acronym / sponsor ID
- Survibase / APHP200184
- Conditions
- Mesenteric Ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 4 Jan 2041 (estimated)
- Study completion
- 4 Jan 2041 (estimated)
- First posted
- 9 Feb 2021 (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.
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%.
Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors.
Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient.
The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described.
The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.
Detailed description
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%.
Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors.
Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient.
The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described.
The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- active patient file of the SURVI service
Key inclusion criteria (5 listed)
- Age > 18 years old
- IMVI including :
- acute mesenteric ischaemia defined by acute digestive distress in relation to arterial and/or venous, occlusive and/or non-occlusive splanchnic-mesenteric vascular insufficiency, in the absence of an alternative diagnosis
Key exclusion criteria (9 listed)
- Left ischaemic colitis without damage to the celiac trunk and/or superior mesenteric artery
- Dissection of the abdominal aorta without intestinal ischaemia
- Portal thrombosis without extension to the superior mesenteric vein
- Portal thrombosis without extension to the superior mesenteric vein
- Traumatic rupture of the digestive arteries
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
mortality of Intestinal Ischemia
Time frame: 1 year
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases (IIVD) at 1 year in terms of mortality.
mortality of Intestinal Ischemia
Time frame: 5 years
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases (IIVD) at 5 years in terms of mortality.
Vascular Diseases (IIVD)
Time frame: 1 year
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases
Vascular Diseases (IIVD)
Time frame: 5 years
To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases
10 secondary outcomes
Describe the prevalence of IIVD
Time frame: 1 year
Describe the prevalence of IIVD
Time frame: 5 years
Study mortality and its associated factors of IIVD
Time frame: 1 year
Study mortality and its associated factors of IIVD
Time frame: 5 years
Study the risk of intestinal resection of IIVD and its associated factors. Among resected patients, describe the incidence of short intestinal syndrome and dependence on parenteral nutrition
Time frame: 1 year
Study the risk of intestinal resection of IIVD and its associated factors. Among resected patients, describe the incidence of short intestinal syndrome and dependence on parenteral nutrition
Time frame: 5 years
To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors
Time frame: 1 year
To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors
Time frame: 5 years
To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.
Time frame: 1 year
To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
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 Mesenteric Ischemia, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Feb 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier CORCOS (0140875000, olivier.corcos@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality of Intestinal Ischemia (time frame: 1 year). The study lists 4 primary outcomes in all. 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 9 Feb 2021.