Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-04 @ 12:33 AM
Study NCT ID:
NCT03354767
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2016-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-20', 'releaseDate': '2019-12-04'}, {'resetDate': '2020-01-15', 'releaseDate': '2020-01-06'}], 'estimatedResultsFirstSubmitDate': '2019-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '1. Plasma\n2. Serum\n3. Whole blood\n4. Skeletal muscle'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-20', 'studyFirstSubmitDate': '2016-11-11', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Rectus Femoris muscle cross-sectional area (%)', 'timeFrame': '7 days', 'description': 'Percentage change in cross sectional area of Rectus Femoris muscle (cm2) in the first post-operative week, from pre-operative measurement (measured the day before surgery), repeated on day 7 post-operatively'}]}, 'conditionsModule': {'conditions': ['Muscular Diseases']}, 'descriptionModule': {'briefSummary': 'Single-centre observational study over one year investigating the mechanisms of muscle homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery', 'detailedDescription': 'Some patients who are critically ill develop a syndrome of muscle weakness called Intensive Care Unit Acquired Paresis. This syndrome involves the development of severe muscle wasting and weakness and affects all skeletal muscles including the muscles which help one breathe. Muscle wasting and weakness whilst critically ill cause prolongation of mechanical ventilation, longer stays on the ICU, reduced mobility and prolonged rehabilitation in survivors. It has also been shown to increase the risk of death on ICU, due to an inability to wean patients from mechanical ventilation. Most patients recover; however in some, the effects last for many years and patients may not recover fully.\n\nAlthough there is some understanding of why this syndrome develops, the molecular processes underlying the muscle wasting are not well understood. From the current scientific evidence, the investigators have identified a group or family of proteins believed to be important in the development of this condition, the activity of which are regulated by disease processes thought to lead to Intensive Care Unit Acquired Paresis (e.g. infection, inflammation, oxidative stress, immobility).\n\nThis research aims to investigate the role of these proteins in human tissue from patients who are at risk of Intensive Care Unit Acquired paresis. Even patients who do not go on to develop the full syndrome, in the early stages of ICU care, show some signs of muscle changes and loss of strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing major aortic or aortic valve surgery requiring cardiopulmonary bypass and aortic cross-clamping', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult (\\>18) patients undergoing major aortic or aortic valve surgery\n\nExclusion Criteria:\n\n* Pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)'}, 'identificationModule': {'nctId': 'NCT03354767', 'acronym': 'RIMMAS', 'briefTitle': 'The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Observational Study Into the Effect on Muscle Wasting and Multiple Organ Function of Ischaemia-reperfusion Injury After Major Aortic Surgery', 'orgStudyIdInfo': {'id': 'ImperialC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wasting patients', 'description': 'Patients with \\>10% loss of skeletal muscle one week after major aortic surgery', 'interventionNames': ['Procedure: Aortic and aortic valve surgery']}, {'label': 'Non-wasting patients', 'description': 'Patients with \\<10% loss of skeletal muscle one week after major aortic surgery', 'interventionNames': ['Procedure: Aortic and aortic valve surgery']}], 'interventions': [{'name': 'Aortic and aortic valve surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Non-wasting patients', 'Wasting patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-12-04', 'type': 'RELEASE'}, {'date': '2019-12-20', 'type': 'RESET'}, {'date': '2020-01-06', 'type': 'RELEASE'}, {'date': '2020-01-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}