Mesenteric IschemiaNCT03484442
Multislice Computed Tomography Angiography in Acute Mesenteric Ischemia
An observational study of Mesenteric Ischemia, run by Assiut University.
Trial summary
Acute mesenteric ischemia is a life-threatening condition with high mortality. Acute mesenteric ischemia is responsible for fewer than one in 1000 hospital admissions, but its mortality rate ranges between 30% and 90% . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mesenteric Ischemia
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinically suspected acute mesentric ischemia based on physician evaluation Patients should be evaluated during 48 h of acute presentation
Who may be able to join
- Clinically suspected acute mesenteric ischemia based on physician evaluation Patients should be evaluated during 48 h of acute presentation
Who cannot join
- Renal Impairment
- Known allergy to iodine contrast media.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Multislice Computed Tomography Angiography In Diagnosis oF Clinically Suspected Acute Mesenteric Ischemia
Acute mesenteric ischemia is a life-threatening condition with high mortality. Acute mesenteric ischemia is responsible for fewer than one in 1000 hospital admissions, but its mortality rate ranges between 30% and 90% . Acute mesenteric ischemia is most commonly secondary to embolism followed by arterial thrombosis, non-occlusive ischemia, and less commonly venous thrombosis . Delay in diagnosis contributes to the continued high mortality rate. Early diagnosis and prompt effective treatment are essential to Correspondence to improve clinical outcomes
Read the detailed description
However, Acute mesenteric ischemia represents a major diagnostic challenge because of its varied presentations and multiple causes . Patients usually present with non-specific abdominal symptoms and laboratory findings, which leads to delayed diagnoses . Therefore, diagnostic imaging has emerged as one of the most crucial components in the diagnostic work-up of suspected
Recent technical advances have made computed tomography angiography the modality of choice in the setting of suspected Acute mesenteric ischemia.computed tomography angiography is a rapid and non-invasive diagnostic tool for assessing intestinal vasculature and bowel . computed tomography angiography allows early diagnosis and differentiation between occlusive and non-occlusive causes, which is important to direct therapeutic approach . Overall, combining vascular and bowel assessment results in a high diagnostic accuracy . A recent meta-analysis showed a sensitivity of 93% and a specificity of 96% . However, this meta analysis also showed that the prevalence of confirmed .Acute mesenteric ischemia is less than 25% among the patients referred to computed tomography angiograph in the setting of suspected Acute mesenteric ischemia .Knowledge of the prevalence and the demographic distribution of alternative diagnoses in the remaining three-fourths of patients without Acute mesenteric ischemia is important for appropriate patient care. computed tomography angiograph is considered to allow for a variety of acute alternative diagnoses, ensuring timely triage of these patients.
- 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.
rate of diagnosis of Acute mesenteric ischemia
number of patients accurately diagnosed acute mesenteric ischemia by multislice computed tomography angiography
Measured: 48 hours of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Fawzy Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484442
- Sponsor's protocol ID
- CTA
- Status last verified
- Mar 2018
- First submitted
- 24 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ottinger LW. Mesenteric ischemia. N Engl J Med. 1982 Aug 26;307(9):535-7. doi: 10.1056/NEJM198208263070905. No abstract available.
PubMed 7048095Ozden N, Gurses B. Mesenteric ischemia in the elderly. Clin Geriatr Med. 2007 Nov;23(4):871-87, vii-viii. doi: 10.1016/j.cger.2007.07.001.
PubMed 17923343Herbert GS, Steele SR. Acute and chronic mesenteric ischemia. Surg Clin North Am. 2007 Oct;87(5):1115-34, ix. doi: 10.1016/j.suc.2007.07.016.
PubMed 17936478Paterno F, Longo WE. The etiology and pathogenesis of vascular disorders of the intestine. Radiol Clin North Am. 2008 Sep;46(5):877-85, v. doi: 10.1016/j.rcl.2008.06.005.
PubMed 19103137Reginelli A, Iacobellis F, Berritto D, Gagliardi G, Di Grezia G, Rossi M, Fonio P, Grassi R. Mesenteric ischemia: the importance of differential diagnosis for the surgeon. BMC Surg. 2013;13 Suppl 2(Suppl 2):S51. doi: 10.1186/1471-2482-13-S2-S51. Epub 2013 Oct 8.
PubMed 24267670Cudnik MT, Darbha S, Jones J, Macedo J, Stockton SW, Hiestand BC. The diagnosis of acute mesenteric ischemia: A systematic review and meta-analysis. Acad Emerg Med. 2013 Nov;20(11):1087-100. doi: 10.1111/acem.12254.
PubMed 24238311Martinez JP, Hogan GJ. Mesenteric ischemia. Emerg Med Clin North Am. 2004 Nov;22(4):909-28. doi: 10.1016/j.emc.2004.05.002.
PubMed 15474776Sise MJ. Acute mesenteric ischemia. Surg Clin North Am. 2014 Feb;94(1):165-81. doi: 10.1016/j.suc.2013.10.012.
PubMed 24267504Ofer A, Abadi S, Nitecki S, Karram T, Kogan I, Leiderman M, Shmulevsky P, Israelit S, Engel A. Multidetector CT angiography in the evaluation of acute mesenteric ischemia. Eur Radiol. 2009 Jan;19(1):24-30. doi: 10.1007/s00330-008-1124-5. Epub 2008 Aug 9.
PubMed 18690454Menke J. Diagnostic accuracy of multidetector CT in acute mesenteric ischemia: systematic review and meta-analysis. Radiology. 2010 Jul;256(1):93-101. doi: 10.1148/radiol.10091938.
PubMed 20574087
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multislice Computed Tomography Angiography In Diagnosis oF Clinically Suspected Acute Mesenteric Ischemia
- ClinicalTrials.gov ID
- NCT03484442
- Acronym / sponsor ID
- CTA
- Conditions
- Mesenteric Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 30 Mar 2018 (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 is a life-threatening condition with high mortality. Acute mesenteric ischemia is responsible for fewer than one in 1000 hospital admissions, but its mortality rate ranges between 30% and 90% . Acute mesenteric ischemia is most commonly secondary to embolism followed by arterial thrombosis, non-occlusive ischemia, and less commonly venous thrombosis . Delay in diagnosis contributes to the continued high mortality rate. Early diagnosis and prompt effective treatment are essential to Correspondence to improve clinical outcomes
Detailed description
However, Acute mesenteric ischemia represents a major diagnostic challenge because of its varied presentations and multiple causes . Patients usually present with non-specific abdominal symptoms and laboratory findings, which leads to delayed diagnoses . Therefore, diagnostic imaging has emerged as one of the most crucial components in the diagnostic work-up of suspected
Recent technical advances have made computed tomography angiography the modality of choice in the setting of suspected Acute mesenteric ischemia.computed tomography angiography is a rapid and non-invasive diagnostic tool for assessing intestinal vasculature and bowel . computed tomography angiography allows early diagnosis and differentiation between occlusive and non-occlusive causes, which is important to direct therapeutic approach . Overall, combining vascular and bowel assessment results in a high diagnostic accuracy . A recent meta-analysis showed a sensitivity of 93% and a specificity of 96% . However, this meta analysis also showed that the prevalence of confirmed .Acute mesenteric ischemia is less than 25% among the patients referred to computed tomography angiograph in the setting of suspected Acute mesenteric ischemia .Knowledge of the prevalence and the demographic distribution of alternative diagnoses in the remaining three-fourths of patients without Acute mesenteric ischemia is important for appropriate patient care. computed tomography angiograph is considered to allow for a variety of acute alternative diagnoses, ensuring timely triage of these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinically suspected acute mesentric ischemia based on physician evaluation Patients should be evaluated during 48 h of acute presentation
Key inclusion criteria (1 listed)
- Clinically suspected acute mesenteric ischemia based on physician evaluation Patients should be evaluated during 48 h of acute presentation
Key exclusion criteria (2 listed)
- Renal Impairment
- Known allergy to iodine contrast media.
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
rate of diagnosis of Acute mesenteric ischemia
Time frame: 48 hours of presentation
number of patients accurately diagnosed acute mesenteric ischemia by multislice computed tomography angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Background: PubMed 7048095Ottinger LW. Mesenteric ischemia. N Engl J Med. 1982 Aug 26;307(9):535-7. doi: 10.1056/NEJM198208263070905. No abstract available.
- Background: PubMed 17923343Ozden N, Gurses B. Mesenteric ischemia in the elderly. Clin Geriatr Med. 2007 Nov;23(4):871-87, vii-viii. doi: 10.1016/j.cger.2007.07.001.
- Background: PubMed 17936478Herbert GS, Steele SR. Acute and chronic mesenteric ischemia. Surg Clin North Am. 2007 Oct;87(5):1115-34, ix. doi: 10.1016/j.suc.2007.07.016.
- Background: PubMed 19103137Paterno F, Longo WE. The etiology and pathogenesis of vascular disorders of the intestine. Radiol Clin North Am. 2008 Sep;46(5):877-85, v. doi: 10.1016/j.rcl.2008.06.005.
- Background: PubMed 24267670Reginelli A, Iacobellis F, Berritto D, Gagliardi G, Di Grezia G, Rossi M, Fonio P, Grassi R. Mesenteric ischemia: the importance of differential diagnosis for the surgeon. BMC Surg. 2013;13 Suppl 2(Suppl 2):S51. doi: 10.1186/1471-2482-13-S2-S51. Epub 2013 Oct 8.
- Background: PubMed 24238311Cudnik MT, Darbha S, Jones J, Macedo J, Stockton SW, Hiestand BC. The diagnosis of acute mesenteric ischemia: A systematic review and meta-analysis. Acad Emerg Med. 2013 Nov;20(11):1087-100. doi: 10.1111/acem.12254.
- Background: PubMed 15474776Martinez JP, Hogan GJ. Mesenteric ischemia. Emerg Med Clin North Am. 2004 Nov;22(4):909-28. doi: 10.1016/j.emc.2004.05.002.
- Background: PubMed 24267504Sise MJ. Acute mesenteric ischemia. Surg Clin North Am. 2014 Feb;94(1):165-81. doi: 10.1016/j.suc.2013.10.012.
- Background: PubMed 18690454Ofer A, Abadi S, Nitecki S, Karram T, Kogan I, Leiderman M, Shmulevsky P, Israelit S, Engel A. Multidetector CT angiography in the evaluation of acute mesenteric ischemia. Eur Radiol. 2009 Jan;19(1):24-30. doi: 10.1007/s00330-008-1124-5. Epub 2008 Aug 9.
- Background: PubMed 20574087Menke J. Diagnostic accuracy of multidetector CT in acute mesenteric ischemia: systematic review and meta-analysis. Radiology. 2010 Jul;256(1):93-101. doi: 10.1148/radiol.10091938.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesenteric Ischemia, run by Assiut University.
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 2 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 30 Mar 2018. 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?
Contact Afaf Abdel-Qader Hasan Elmamlok, professor (02208843124, afaf.kader@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of diagnosis of Acute mesenteric ischemia (time frame: 48 hours of presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484442, which also lists 10 linked publications.
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 30 Mar 2018.