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RecruitingNCT04746534SurvibaseUpdated Feb 9, 2021

Cohort SURVI : Intestinal Ischemia and Vascular Diseases

An observational study in Mesenteric Ischemia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Started Nov 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
20,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Mesenteric Ischemia

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03

In context

Mesenteric Ischemia

40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 154 across 26 observational studies indexed under Mesenteric Ischemia.

Browse Mesenteric Ischemia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

active patient file of the SURVI service

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
20,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 5 years

  3. Vascular Diseases (IIVD)

    To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases

    Time frame: 1 year

  4. Vascular Diseases (IIVD)

    To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases

    Time frame: 5 years

Secondary outcomes

  1. Describe the prevalence of IIVD

    Time frame: 1 year

  2. Describe the prevalence of IIVD

    Time frame: 5 years

  3. Study mortality and its associated factors of IIVD

    Time frame: 1 year

  4. Study mortality and its associated factors of IIVD

    Time frame: 5 years

  5. 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

  6. 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

  7. To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors

    Time frame: 1 year

  8. To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors

    Time frame: 5 years

  9. To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.

    Time frame: 1 year

  10. To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Olivier CORCOS
    Clichy, 92110, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04746534
Responsible party
Sponsor
First posted
Feb 9, 2021
Start date
Nov 27, 2020
Primary completion
Jan 4, 2041 (estimated)
Completion
Jan 4, 2041 (estimated)
Last update
Feb 9, 2021

Study contacts

Olivier CORCOS
Contact
olivier.corcos@aphp.fr
0140875000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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