Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-20 @ 3:00 AM
Study NCT ID:
NCT06841757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "E/e' Ratio (Diastolic Function)", 'timeFrame': 'T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU', 'description': "Echocardiography (Tissue Doppler Imaging) will be used to measure the E/e' ratio, a reliable parameter for assessing left ventricular filling pressure and diastolic function. This is the primary method to evaluate the effect of Remote Ischemic Preconditioning (RIPC) on diastolic function in both diabetic and non-diabetic patients undergoing CABG."}], 'secondaryOutcomes': [{'measure': 'Mitral Inflow Velocities(E/A Ratio)', 'timeFrame': 'T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU', 'description': 'Using TEE to measure E/A ratio'}, {'measure': 'Deceleration Time (DT)', 'timeFrame': 'T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU'}, {'measure': 'Cardiac Troponin Levels', 'timeFrame': 'Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury'}, {'measure': 'Systolic and diastolic Blood pressure', 'timeFrame': 'T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU'}, {'measure': 'Inotropic Support:', 'timeFrame': 'During surgery', 'description': 'Usage and dose.'}, {'measure': 'LVEF', 'timeFrame': 'Compare between start and end of surgery', 'description': 'Ejection fraction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery bypass surgery', 'Diastolic function', 'Remote ischemic preconditioning'], 'conditions': ['Coronary Artery Disease', 'Diabetes Mellitus', 'Diastolic Function']}, 'referencesModule': {'references': [{'pmid': '33309175', 'type': 'BACKGROUND', 'citation': 'Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.'}]}, 'descriptionModule': {'briefSummary': "This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.\n* Both males and females will be included.\n* In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months\n* During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.\n* Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.\n* Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery\n\nExclusion Criteria:\n\n* Combined CABG and valve surgery, emergency CABG.\n* Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months\n* Peripheral vascular disease (PVD) affecting the upper limbs.\n* Acute coronary syndrome (ACS); acute or recent myocardial infarction.\n* Left ventricular ejection fraction ≤30%.\n* Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.\n* Renal failure, defined as eGFR \\< 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).\n* Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.'}, 'identificationModule': {'nctId': 'NCT06841757', 'briefTitle': 'The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery: A Randomized Controlled Study Comparing Diabetic and Non-Diabetic Patients', 'orgStudyIdInfo': {'id': 'MD-342-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetic with Remote ischemic preconditioning', 'description': 'Remote Ischemic Preconditioning (RIPC) Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation.', 'interventionNames': ['Behavioral: Remote ischemic preconditioning']}, {'type': 'EXPERIMENTAL', 'label': 'Non diabetic with Remote ischemic preconditioning', 'description': 'Remote Ischemic Preconditioning (RIPC) Non-diabetic patients who undergo Remote ischemic preconditioning using the same ischemia/reperfusion protocol as the diabetic group.', 'interventionNames': ['Behavioral: Remote ischemic preconditioning']}, {'type': 'NO_INTERVENTION', 'label': 'Diabetic without Remote ischemic preconditioning', 'description': 'Diabetic patients who receive standard care for CABG surgery without Remote ischemic preconditioning'}, {'type': 'NO_INTERVENTION', 'label': 'Non diabetic without Remote ischemic preconditioning', 'description': 'Non-diabetic patients who receive standard care for CABG surgery without RIPC.'}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'BEHAVIORAL', 'description': 'Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation', 'armGroupLabels': ['Diabetic with Remote ischemic preconditioning', 'Non diabetic with Remote ischemic preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Alagaty Ehsan Alagaty, Professor of anesthesia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alzahraa Khalil Marie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer in Cairo university', 'investigatorFullName': 'Alzahraa Khalil Marie', 'investigatorAffiliation': 'Cairo University'}}}}