Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02706860
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2016-03-08
Brief Title:
Efficacy of Different Perioperative Statin Regimens on the Protection Against Post Coronary Artery Bypass Grafting Major Adverse Cardio-cerebral Events
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims at comparing different perioperative statin regimens for the prevention of post CABG adverse events
This was a randomized prospective clinical trial Ninety four patients scheduled for elective isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups 80 mg atorvastatinday for 2 days preoperatively N37 80 mg atorvastatinday for 5-9 days preoperatively N28 or 40 mg atorvastatinday for 5-9 days preoperatively N29 The corresponding preoperative doses were restarted postoperatively post-op when patients were able to take the medication orally and were continued for one month Cardiac troponin I TnI Creatine Kinase CK-MB and C-reactive protein CRP were assayed preoperatively and post-operatively at 8 24 48 hours and at discharge Marker levels were compared among the three groups The incidence of post-operative major adverse cardiac and cerebrovascular events MACCE was assessed including 30-day all-cause mortality myocardial infarction atrial fibrillation ventricular tachycardiaventricular fibrillation stroke and target-vessel revascularization The incidence of renal or hepatic impairment and post-operative infections were also assessed A Quality of life QoL questionnaire EQ-5D-3L was administered preoperatively and 1 month after CABG
This was a randomized prospective clinical trial Ninety four patients scheduled for elective isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups 80 mg atorvastatinday for 2 days preoperatively N37 80 mg atorvastatinday for 5-9 days preoperatively N28 or 40 mg atorvastatinday for 5-9 days preoperatively N29 The corresponding preoperative doses were restarted postoperatively post-op when patients were able to take the medication orally and were continued for one month Cardiac troponin I TnI Creatine Kinase CK-MB and C-reactive protein CRP were assayed preoperatively and post-operatively at 8 24 48 hours and at discharge Marker levels were compared among the three groups The incidence of post-operative major adverse cardiac and cerebrovascular events MACCE was assessed including 30-day all-cause mortality myocardial infarction atrial fibrillation ventricular tachycardiaventricular fibrillation stroke and target-vessel revascularization The incidence of renal or hepatic impairment and post-operative infections were also assessed A Quality of life QoL questionnaire EQ-5D-3L was administered preoperatively and 1 month after CABG
Detailed Description:
This study was conducted at the National Heart Institute NHI Cairo Egypt during the period between June 2013 and February 2015 It was approved by the ethics committee at the Faculty of Pharmacy Cairo University and the scientific committee at the NHI An informed consent was obtained from all study participants after they have been approached with the nature purpose and possible risks of the study
Preoperative baseline demographic characteristics preoperative medications comorbid conditions and risk factors were identified and summarized
Design This is a randomized prospective interventional open label study Upon admission to the NHI eligible patients were randomly assigned to one of 3 treatment groups group I 80 mg atorvastatinday for 2 days preoperatively group II 40 mg atorvastatinday for 5-9 days preoperatively or group III 80 mg atorvastatinday for 5-9 days preoperatively Atorvastatin doses were reinitiated postoperatively as soon as patients could take the medication orally and was continued for one month after operation
The following intra-operative data were recorded for each patient cardiopulmonary bypass time aortic clamp time type of anesthesia number of grafts and need for blood transfusion
Blood samples were drawn preoperatively baseline then at 8 hours 24 hours 48 hours postoperatively and before hospital discharge Blood samples were spun and sera were separated stored according to the storage conditions specified by the manufacturer and used to measure the TnI CK-MB and CRP at the time of analysis Cardiac TnI was assayed by the Dimension TNI method a homogenous sandwich chemiluminescent assay based on LOCI technology using SIEMENS Dimension EXL LOCI Module system Siemens Healthcare Diagnostics Inc Newark USA CK-MB isoenzyme was measured by the Mass MMB method a one-step enzyme immunoassay based on the sandwich principle using SIEMENS Dimension Heterogeneous Immunoassay Module system Siemens Healthcare Diagnostics Inc Newark USA CRP was measured by the C-Reactive Protein Extended Range RCRP method a method based on a particle enhanced turbidimetric immunoassay PETIA technique using SIEMENS Dimension system Siemens Healthcare Diagnostics Inc Newark USA
A-12 lead electrocardiogram ECG was performed pre-operatively in the intensive care unit ICU and upon patient transfer to the ward The appearance of new Q-waves indicating myocardial infarction MI or incidence of any arrhythmias was reported Echocardiography was performed pre-operatively and post-operatively after ICU discharge to detect any new wall movement abnormalities as well
Measured end points were as follows 1 Incidence of post-operative major adverse cardiac and cerebrovascular events MACCE including 30-days all-cause mortality MI AF ventricular tachycardia or ventricular fibrillation debilitating stroke or transient ischemic attack TIA or target-vessel revascularization 2 renal impairment 3 hepatic impairment 4 postoperative infections 5 persistent blood glucose abnormalities 6 length of ICU and hospital stays and a health-related quality-of-life HRQoL HRQoL was assessed using the Euro Quality of Life 5-Dimensional Classification EQ-5D-3L 19 at baseline preoperatively as patients were admitted to the NHI and then one month postoperatively during the follow-up visit or by contacting the patient via a phone call
Preoperative baseline demographic characteristics preoperative medications comorbid conditions and risk factors were identified and summarized
Design This is a randomized prospective interventional open label study Upon admission to the NHI eligible patients were randomly assigned to one of 3 treatment groups group I 80 mg atorvastatinday for 2 days preoperatively group II 40 mg atorvastatinday for 5-9 days preoperatively or group III 80 mg atorvastatinday for 5-9 days preoperatively Atorvastatin doses were reinitiated postoperatively as soon as patients could take the medication orally and was continued for one month after operation
The following intra-operative data were recorded for each patient cardiopulmonary bypass time aortic clamp time type of anesthesia number of grafts and need for blood transfusion
Blood samples were drawn preoperatively baseline then at 8 hours 24 hours 48 hours postoperatively and before hospital discharge Blood samples were spun and sera were separated stored according to the storage conditions specified by the manufacturer and used to measure the TnI CK-MB and CRP at the time of analysis Cardiac TnI was assayed by the Dimension TNI method a homogenous sandwich chemiluminescent assay based on LOCI technology using SIEMENS Dimension EXL LOCI Module system Siemens Healthcare Diagnostics Inc Newark USA CK-MB isoenzyme was measured by the Mass MMB method a one-step enzyme immunoassay based on the sandwich principle using SIEMENS Dimension Heterogeneous Immunoassay Module system Siemens Healthcare Diagnostics Inc Newark USA CRP was measured by the C-Reactive Protein Extended Range RCRP method a method based on a particle enhanced turbidimetric immunoassay PETIA technique using SIEMENS Dimension system Siemens Healthcare Diagnostics Inc Newark USA
A-12 lead electrocardiogram ECG was performed pre-operatively in the intensive care unit ICU and upon patient transfer to the ward The appearance of new Q-waves indicating myocardial infarction MI or incidence of any arrhythmias was reported Echocardiography was performed pre-operatively and post-operatively after ICU discharge to detect any new wall movement abnormalities as well
Measured end points were as follows 1 Incidence of post-operative major adverse cardiac and cerebrovascular events MACCE including 30-days all-cause mortality MI AF ventricular tachycardia or ventricular fibrillation debilitating stroke or transient ischemic attack TIA or target-vessel revascularization 2 renal impairment 3 hepatic impairment 4 postoperative infections 5 persistent blood glucose abnormalities 6 length of ICU and hospital stays and a health-related quality-of-life HRQoL HRQoL was assessed using the Euro Quality of Life 5-Dimensional Classification EQ-5D-3L 19 at baseline preoperatively as patients were admitted to the NHI and then one month postoperatively during the follow-up visit or by contacting the patient via a phone call
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None