Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02014012
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PWV for Cardiovascular Complication After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative cardiovascular complication and parameters', 'timeFrame': 'within the first 7 days after surgery', 'description': 'Stroke, Delirium, Newly developed atrial fibrillation, ARF, Peak CK-MB and troponin I levels measured at 12 and 24 hours after surgery, Peak estimated GFR and corresponding creatinine'}], 'secondaryOutcomes': [{'measure': "E/e' and e' measured by transthoracic echocardiography with color-coded tissue dopper imaging in patients undergoing non-valvular cardiac surgery", 'timeFrame': 'baseline and within the first 14 days after surgery', 'description': "peak early transmitral filling velocity during early diastole (E), mean early velocity at the septal mitral annulus (e')"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['C.Surgical Procedure; Cardiac']}, 'descriptionModule': {'briefSummary': 'Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac surgery patients who sign the informed consent\n\nExclusion Criteria:\n\n* Chronic renal failure (Cr\\>1.5mg/dL), Dialysis patients\n* Previous stroke\n* Left ventricular dysfunction (EF \\<50%)\n* ASO with claudication\n* \\< 40 years'}, 'identificationModule': {'nctId': 'NCT02014012', 'briefTitle': 'PWV for Cardiovascular Complication After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study', 'orgStudyIdInfo': {'id': '16-2013-40'}, 'secondaryIdInfos': [{'id': 'PWV-OHS', 'type': 'OTHER', 'domain': 'SMG-SNU Boramae Medical Center'}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jae-Sung Choi, MD. PhD.', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}