Cohort SURVI : Intestinal Ischemia and Vascular Diseases

Mesenteric Ischemia Clinical Trial

— Survibase  

Official title:

Cohort SURVI : Intestinal Ischemia and Vascular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746534
• Other study ID #: APHP200184
• Status: Recruiting
• Start date: November 27, 2020
• Est. completion date: January 4, 2041

Study information

• Verified date: November 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier CORCOS
• Phone: 0140875000
• Email: olivier.corcos[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: January 4, 2041
• Est. primary completion date: January 4, 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Ischemia
• Mesenteric Ischemia
• Vascular Diseases

Locations

Country	Name	City	State
France	Olivier CORCOS	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	5 years
Primary	Vascular Diseases (IIVD)	To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases	1 year
Primary	Vascular Diseases (IIVD)	To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases	5 years
Secondary	Describe the prevalence of IIVD		1 year
Secondary	Describe the prevalence of IIVD		5 years
Secondary	Study mortality and its associated factors of IIVD		1 year
Secondary	Study mortality and its associated factors of IIVD		5 years
Secondary	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		1 year
Secondary	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		5 years
Secondary	To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors		1 year
Secondary	To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors		5 years
Secondary	To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.		1 year
Secondary	To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.		5 years