Acute Mesenteric Ischemia, Reality in Catalonia | NCT06428240

Studies
Acute Mesenteric Ischemia, Reality in Catalonia

NCT06428240

Sponsor

Hospital del Mar

Status

Unknown status

Last Update Posted

Jun 3, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute Mesenteric Ischemia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

May 20, 2024

First Submission Date that Met QC Criteria

May 20, 2024

First Posted Date

May 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2024

Last Update Posted Date

Jun 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ana María González Castillo, Doctor, Hospital del MarPrincipal Investigator

Lead Sponsor

Hospital del MarOTHER

Collaborators

Name	Class
Hospital Clinic of Barcelona	OTHER
Germans Trias i Pujol Hospital	OTHER
Parc Taulí Hospital Universitari	OTHER
Hospital de la Santa creu i Sant Pau - Barcelona

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but not very extended. The aim of this study is to analyse the results of the patients admited with an AMI in Catalonia.

Detailed Description

Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality from 50 to 80%. Even though AMI is a relatively rare condition (1:1,000) the incidence rises exponentially with increasing age, in patients older than 75 years, the incidence of AMI has been reported higher than that of acute appendicitis. AMI patients benefit from early assessment in a surgical unit with capabilities to definitive management. The diagnosis and management of AMI are truly multidisciplinary, requiring high index of suspicion and awareness from emergency department physicians, preferably computed tomography angiography with precise interpretation, but usually this is not the truth reality and the diagnostic is delayed as well as the treatment, and the management is not multidisciplinary.

The aim of this study is to analyse the management and results of the patients admitted with an AMI in Catalonia from November 2024 to April 2026.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	To describe the mortality in patients with a diagnostic of AMI	2024-2026

Secondary Outcomes

Measure	Description	Time Frame
Complications	To describe the complications in patients with a diagnostic of AMI	2024-2026
Management	To describe the management in patients with a diagnostic of AMI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnostic of Acute Mesenteric Ischemia

Exclusion Criteria:

Chronic Mesenteric Ischemia
Ischemic Colitis
Bowel obstruction strangulation
Inflammatory bowel necrosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study populations is all pacients with the diagnostic of Acute Mesenteric Ischemia that are admitted in the Hospital in Catalonia.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42154050	Derived	Gonzalez-Castillo AM, Calsina Juscafresa L, Gelabert A, Velescu A, Marrano E, Vikatmaa P, Tolonen M. The real-world management of acute mesenteric ischemia in Spain: results from a multicenter national survey. Eur J Trauma Emerg Surg. 2026 May 19;52(1):167. doi: 10.1007/s00068-026-03209-1.

ID	Term
D065666	Mesenteric Ischemia
D015746	Abdominal Pain

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010532	Peritoneal Diseases