Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT05490394
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2022-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Study of PAI-1 4G/5G Polymorphism and Postoperative AKI in Patients With Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who develop postoperative moderate to severe AKI', 'timeFrame': 'from time of the end of surgery; assessed up to 7 days', 'description': 'number of participants who develop stage 2 to stage 3 AKI after the surgery'}], 'secondaryOutcomes': [{'measure': 'Number of participants who develop postoperative AKI', 'timeFrame': 'from time of the end of surgery; assessed up to 7 days', 'description': 'number of participants who develop all stage AKI after the surgery'}, {'measure': 'In-hospital mortality', 'timeFrame': 'from time of the end of surgery; assessed up to 7 days', 'description': 'incidence of deaths happened after surgery during the hospital stay'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'from time of the end of surgery; assessed up to 7 days', 'description': 'duration of postoperative stay in hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AKI - Acute Kidney Injury', 'PAI-1 4G/5G Polymorphism', 'Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'To explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI in Stanford type A dissection patients undergoing open-heart repair surgery.', 'detailedDescription': "The incidence of postoperative acute kidney injury（AKI）after cardiac surgery is high, especially in patients with aortic dissection. Moderate to severe postoperative AKI (stage 2 and 3 AKI) is closely related to the poor prognosis after cardiac surgery. Patients with Stanford type A dissection who suffered from stage 2 and 3 postoperative AKI will have a 4.45 times higher mortality than that of patients without AKI. At present, there is no effective treatment for cardiac surgery associated AKI (CSA-AKI), and prevention is more important than treatment. Therefore, screening high-risk patients and implementing individualized preventive measures are of great significance for the prevention of postoperative AKI and improvement of prognosis of patients.\n\nThe previous completed RCT study in the investigators' center showed that perioperative administration of inhaled nitric oxide (NO) to patients undergoing cardiopulmonary bypass (CPB) assisted multivalve replacement surgery could significantly reduce the incidence of postoperative AKI, but the NO should be provided before CPB was started, that is, when injury began. This phenomenon implied that NO played a preventive role rather than a therapeutic role. In further studies, the investigators found that the kidney protective mechanism of NO inhalation may be related to its role on PAI-1 regulation. According to the literature, the 4G5G polymorphism in the promoter region of PAI-1 is a natural regulator of the expression level of PAI-1 in vivo. Based on these findings, the investigators reviewed some cases who underwent aortic dissection correction surgery and also PAI-1 4G5G polymorphism test in our hospital, the investigators found that 4G/4G homozygous patients had a much higher proportion of moderate to severe AKI than 4G5G heterozygous patients or 5G/5G homozygous patients. However, due to the small sample size, the differences in AKI incidence between different genotype groups were not statistical significant.\n\nIn order to further explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI, the investigators planed to expand the sample size and form a ambispective cohort study which include the retrospective cohort mentioned above and a new prospective cohort study. A total of 255 patients will be included to determine the genetic susceptibility of CSA-AKI associated with PAI-1 4G5G deletion / insertion polymorphism. All subjects included in the prospective part of this study will receive PAI-1 4G5G polymorphism test, and record whether postoperative AKI occurs and also AKI stage. There is no other intervention for patients included in this study in addition to blood collection. All medical decision-making processes in hospital will not be interfered by the research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For retrospective cohort: patients who previously underwent open thoracic aortic dissection correction surgery and also underwent PAI-1 4G5G polymorphism in Xijing Hospital.\n\nFor prospective cohort: patients who is scheduled for open thoracic aortic dissection correction surgery (total aortic arch replacement, with or without aortic valve replacement) in Xijing Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stanford type A aortic dissection patient admitted to the Department of Cardiology, in Xijing Hospital\n* Open thoracic aortic dissection correction (total aortic arch replacement with or without aortic valve replacement) is proposed\n* Age ≥ 18 years old\n* Informed consent has been signed\n\nExclusion Criteria:\n\n* Cardiopulmonary bypass assisted cardiac surgery has been performed in the past three months\n* Renal failure patients who have started or are receiving dialysis treatment before operation'}, 'identificationModule': {'nctId': 'NCT05490394', 'briefTitle': 'Correlation Study of PAI-1 4G/5G Polymorphism and Postoperative AKI in Patients With Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Ambispective Cohort Study on the Correlation Between 4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 (PAI-1) Promoter and Moderate to Severe Postoperative Acute Renal Injury in Patients With Aortic Dissection', 'orgStudyIdInfo': {'id': 'KY20212193-F-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chong Lei, MD & phD', 'investigatorAffiliation': 'Xijing Hospital'}}}}