Acute Mesenteric IschemiaAMI_HMARNCT06310395
Analysis of the Acute Mesenteric Ischemia in a Single Institution Over 10 Years
An observational study of Acute Mesenteric Ischemia, run by Hospital del Mar.
Trial summary
Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but it is not the reality in many Hospitals. The aim of this study is to analyse the results of the patients admitted with an AMI in Hospital de Mar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mesenteric Ischemia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admited in Hospital del Mar from 2014 to 2023 with a diagnostic of AMI
Who may be able to join
- Acute Mesenteric Ischemia
Who cannot join
- Chronic Mesenteric Ischemia
- Ischemic Colitis
- Bowel obstruction strangulation
- Inflamatory bowel necrosis
About this study
Official title: Analysis of the Acute Mesenteric Ischemia Management in a Single Institution Over 10 Years
Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but it is not the reality in many Hospitals.
The aim of this study is to analyse the results of the patients admitted with an AMI in Hospital de Mar.
Read the detailed description
Acute mesenteric ischemia (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.
The aim of this study is to analyse the results of the patients admitted with an AMI in Hospital de Mar from January 2014 to December 2023.
- Conditions
- Acute Mesenteric Ischemia
- Keywords
- Mesenteric ischemia, Acute Mesenteric ischemia, Abdominal pain, Elderly, Complications, Mortality
- Medical subject headings
- Mesenteric Ischemia, Abdominal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To describe the mortality in patients with a diagnostic of AMI
Measured: 2014-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mesenteric IschemiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María González Castillo, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310395
- Sponsor's protocol ID
- AMI_H.MAR
- Acronym
- AMI_HMAR
- Status last verified
- May 2024
- First submitted
- 7 Mar 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Acute Mesenteric Ischemia Management in a Single Institution Over 10 Years
- ClinicalTrials.gov ID
- NCT06310395
- Acronym / sponsor ID
- AMI_HMAR / AMI_H.MAR
- Conditions
- Acute Mesenteric Ischemia
- Keywords
- Mesenteric ischemia, Acute Mesenteric ischemia, Abdominal pain, Elderly, Complications, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 15 Mar 2024 (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.
Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but it is not the reality in many Hospitals.
The aim of this study is to analyse the results of the patients admitted with an AMI in Hospital de Mar.
Detailed description
Acute mesenteric ischemia (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.
The aim of this study is to analyse the results of the patients admitted with an AMI in Hospital de Mar from January 2014 to December 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admited in Hospital del Mar from 2014 to 2023 with a diagnostic of AMI
Key inclusion criteria (1 listed)
- Acute Mesenteric Ischemia
Key exclusion criteria (4 listed)
- Chronic Mesenteric Ischemia
- Ischemic Colitis
- Bowel obstruction strangulation
- Inflamatory bowel necrosis
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
Time frame: 2014-2023
To describe the mortality in patients with a diagnostic of AMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Mesenteric Ischemia, run by Hospital del Mar.
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 4 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Mortality (time frame: 2014-2023). 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 22 May 2024.