Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT06445660
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility of a Radiological Score Based on CT Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-03', 'size': 573510, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-22T05:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency rate', 'timeFrame': 'up to one month', 'description': 'Frequency rate of common radiological signs in AMI patients with and without salvageable bowel.'}], 'secondaryOutcomes': [{'measure': 'Performance of the radiological score', 'timeFrame': 'up to one month', 'description': 'Performance of the radiological score in patients with different types of AMI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Mesenteric Ischemia']}, 'descriptionModule': {'briefSummary': 'Computed tomography (CT) is the standard modality for scanning patients with critical acute abdominal conditions, including suspected acute mesenteric ischemia (AMI). CT imaging can potentially differentiate between reversible and irreversible ischaemic damage of the bowel. This moment is pivotal in selecting the treatment strategy for AMI - in the absence of irreversible damage; reperfusion therapy can preserve intestinal viability, thereby avoiding the need for bowel resection. The present study tests the hypothesis that combining several symptoms may enhance the diagnostic performance of CT scanning in detecting salvageable bowel in patients with AMI. This study is an ancillary component of the AMESI study (Clinical Trials: NCT05218863) - a prospective, multicentre observational study aimed at identifying the incidence and describing the outcomes of acute mesenteric ischemia (AMI) in adult hospitalized patients. The ultimate purpose of the present study is to create a computed tomography-based radiological score for the assessment of bowel viability in patients with AMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a substudy of the AMESI study - "Incidence, Diagnosis, Management, and Outcome of Acute Mesenteric Ischaemia: A Prospective, Multicentre Observational Study." (Clinical Trials: NCT05218863) As of the end of August 2023, a total of 705 patients from 32 study sites worldwide have been enrolled, with 418 of them having confirmed cases of AMI. For patients with confirmed AMI, comprehensive data collection concerning diagnostics, management, and long-term outcomes has been completed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in AMESI study\n* confirmed or suspected acute mesenteric ischaemia\n* CT scan of the entire abdominal cavity / full body using intravenous contrast media is available\n\nExclusion Criteria:\n\n* Scans without the use of an intravenous contrast media or those covering only a partial area of the abdomen will be excluded.'}, 'identificationModule': {'nctId': 'NCT06445660', 'acronym': 'AMESIradiol', 'briefTitle': 'The Feasibility of a Radiological Score Based on CT Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Tartu'}, 'officialTitle': 'The Feasibility of a Radiological Score Based on Quantified Analysis of Computed Tomography Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia: A Retrospective Analysis of Prospective Study', 'orgStudyIdInfo': {'id': '03.01.2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'Patients included in the AMESI study as suspected AMI'}, {'label': 'AMI patients with salvageable bowel', 'description': 'Patients included in the AMESI study with confirmed AMI, who did not undergo bowel resection\n\nPatients with one of the following:\n\n1. treated endovascularly and did not undergo bowel resection secondarily\n2. received surgical revascularization without bowel resection (initial or secondary)\n3. received explorative laparoscopy or laparotomy without the need for bowel resection (initially or secondarily)\n4. received conservative treatment without the need for secondary bowel resection'}, {'label': 'AMI patients with non-salvageable bowel', 'description': 'Patients included in the AMESI study with confirmed AMI who (one of the following):\n\n1. underwent bowel resection initially\n2. underwent bowel resection secondarily\n3. did not undergo bowel resection because non-salvageable bowel\n4. were changed to palliation due to the progression of ischaemia after any initial treatment with curative intention (including endovascular and conservative)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50408', 'city': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Martin Reim, Dr', 'role': 'CONTACT', 'email': 'Martin.Reim@kliinikum.ee'}], 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'centralContacts': [{'name': 'Joel Starkopf', 'role': 'CONTACT', 'email': 'joel.starkopf@ut.ee', 'phone': '53318400', 'phoneExt': '372'}, {'name': 'Kätlin Eiche', 'role': 'CONTACT', 'email': 'Katlin.Eiche@ut.ee'}], 'overallOfficials': [{'name': 'Joel Starkopf', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Tartu, Department of Anaesthesiology and Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tartu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Annika Reintam Blaser', 'investigatorAffiliation': 'University of Tartu'}}}}