Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05192005
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2021-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Blood Pressure and In-hospital Morbidity After Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2021-12-30', 'studyFirstSubmitQcDate': '2021-12-30', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between perioperative mean arterial pressure level in the occurrence of postoperative organ failure', 'timeFrame': 'Day 30', 'description': 'This outcome corresponds to the correlation between preoperative and intraoperative mean arterial pressure levels and the occurrence of postoperative organ failure (composite endpoint).'}], 'secondaryOutcomes': [{'measure': 'Correlation between perioperative mean arterial pressure level and occurrence of postoperative organ failure', 'timeFrame': 'Day 30', 'description': 'This outcome corresponds to the correlation between preoperative and intraoperative mean arterial pressure levels and the occurrence of organ failure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Cardiopathy']}, 'referencesModule': {'references': [{'pmid': '17374814', 'type': 'BACKGROUND', 'citation': "Steg PG, Bhatt DL, Wilson PW, D'Agostino R Sr, Ohman EM, Rother J, Liau CS, Hirsch AT, Mas JL, Ikeda Y, Pencina MJ, Goto S; REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007 Mar 21;297(11):1197-206. doi: 10.1001/jama.297.11.1197."}, {'pmid': '19996066', 'type': 'BACKGROUND', 'citation': 'Bavry AA, Anderson RD, Gong Y, Denardo SJ, Cooper-Dehoff RM, Handberg EM, Pepine CJ. Outcomes Among hypertensive patients with concomitant peripheral and coronary artery disease: findings from the INternational VErapamil-SR/Trandolapril STudy. Hypertension. 2010 Jan;55(1):48-53. doi: 10.1161/HYPERTENSIONAHA.109.142240. Epub 2009 Dec 7.'}, {'pmid': '27590221', 'type': 'BACKGROUND', 'citation': 'Vidal-Petiot E, Ford I, Greenlaw N, Ferrari R, Fox KM, Tardif JC, Tendera M, Tavazzi L, Bhatt DL, Steg PG; CLARIFY Investigators. Cardiovascular event rates and mortality according to achieved systolic and diastolic blood pressure in patients with stable coronary artery disease: an international cohort study. Lancet. 2016 Oct 29;388(10056):2142-2152. doi: 10.1016/S0140-6736(16)31326-5. Epub 2016 Aug 30.'}, {'pmid': '33710168', 'type': 'BACKGROUND', 'citation': 'Yannoutsos A, Lin F, Billuart O, Buronfosse A, Sacco E, Beaussier H, Mourad JJ, Emmerich J, Lazareth I, Priollet P. Low admission blood pressure as a marker of poor 1-year survival in patients with revascularized critical limb ischemia. J Hypertens. 2021 Aug 1;39(8):1611-1620. doi: 10.1097/HJH.0000000000002821.'}, {'pmid': '23263580', 'type': 'BACKGROUND', 'citation': 'Ono M, Arnaoutakis GJ, Fine DM, Brady K, Easley RB, Zheng Y, Brown C, Katz NM, Grams ME, Hogue CW. Blood pressure excursions below the cerebral autoregulation threshold during cardiac surgery are associated with acute kidney injury. Crit Care Med. 2013 Feb;41(2):464-71. doi: 10.1097/CCM.0b013e31826ab3a1.'}, {'pmid': '24075467', 'type': 'BACKGROUND', 'citation': 'Ono M, Brady K, Easley RB, Brown C, Kraut M, Gottesman RF, Hogue CW Jr. Duration and magnitude of blood pressure below cerebral autoregulation threshold during cardiopulmonary bypass is associated with major morbidity and operative mortality. J Thorac Cardiovasc Surg. 2014 Jan;147(1):483-9. doi: 10.1016/j.jtcvs.2013.07.069. Epub 2013 Sep 26.'}, {'pmid': '25256545', 'type': 'BACKGROUND', 'citation': 'Hori D, Brown C, Ono M, Rappold T, Sieber F, Gottschalk A, Neufeld KJ, Gottesman R, Adachi H, Hogue CW. Arterial pressure above the upper cerebral autoregulation limit during cardiopulmonary bypass is associated with postoperative delirium. Br J Anaesth. 2014 Dec;113(6):1009-17. doi: 10.1093/bja/aeu319. Epub 2014 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of hypertension is high, estimated at 80% in patients with cardiovascular (CV) disease. The optimal blood pressure (BP) level for CV prevention remains controversial. Data from the literature highlight that the relationship between BP level and mortality is not linear, but rather J-shaped. In particular, in treated hypertensive patients with stable coronary artery disease, a systolic BP below 120 mm Hg is associated with the risk of recurrent coronary events and CV mortality.\n\nAn inverse relationship was recently demonstrated between BP level before revascularization procedure and mortality at 3 months and 1 year after the procedure in patients managed for critical ischemia. These data underline the need for a personalized approach to the management of hypertension, especially in elderly hypertensive patients with comorbidities.\n\nThe question of the optimal mean BP value also arises in cardiac surgery, especially during extracorporeal circulation in patients undergoing coronary artery bypass grafting. Hypotension during cardiac surgery appears to be associated with renal failure and perioperative mortality in some patients. Conversely, high blood pressure levels (above the cerebral autoregulatory threshold) may be associated with postoperative cognitive impairment and bleeding risk. In hypertensive patients, the autoregulatory capacity of cerebral and renal perfusion is partly impaired, with a greater susceptibility to ischemia in case of hypotension. Personalized blood pressure targets could be beneficial perioperatively with a lower risk of postoperative complications.\n\nThe objective of this protocol is to determine a correlation between perioperative mean arterial pressure level and in-hospital morbidity in a population of patients with ischemic heart disease managed for coronary artery bypass grafting (CABG). The results of this descriptive work would make it possible to introduce the problem of the optimal blood pressure target during extracorporeal circulation according to the existence of peripheral arterial damage and preoperative blood pressure values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic heart disease managed for coronary artery bypass grafting in the cardiac surgery department at Marie Lannelongue Hospital between 01/01/2016 and 12/31/2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient whose age ≥ 18 years\n* Patient with ischemic heart disease managed for coronary artery bypass grafting (CABG) between 01/01/2016 and 12/31/2020\n* French-speaking patient\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under court protection\n* Patient objecting to the use of his data for this research'}, 'identificationModule': {'nctId': 'NCT05192005', 'acronym': 'PA_PAC', 'briefTitle': 'Perioperative Blood Pressure and In-hospital Morbidity After Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Perioperative Blood Pressure and In-hospital Morbidity After Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'PA_PAC'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Alexandra YANNOUTSOS, MD', 'role': 'CONTACT', 'email': 'ayannoutsos@ghpsj.fr'}], 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Alexandra YANNOUTSOS, MD', 'role': 'CONTACT', 'email': 'ayannoutsos@ghpsj.fr', 'phone': '144123568', 'phoneExt': '+33'}, {'name': 'Julien GUIHAIRE, MD', 'role': 'CONTACT', 'email': 'j.guihaire@ghpsj.fr', 'phone': '140948607', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alexandra YANNOUTSOS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}