Ignite Creation Date:
2024-05-05 @ 10:02 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01016509
Status:
COMPLETED
Last Update Posted:
2011-12-21
First Post:
2009-11-18
Brief Title:
Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
Study Overview
Official Title:
Tight Glycemic Control During Angioplasty Revascularization for Acute Coronary Syndrome Reduces Circulating Inflammatory Cytokines and Coronary Stent Restenosis
Status:
COMPLETED
Status Verified Date:
2011-12
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:
A multicentric study will evaluate whether peri-procedural tight glycemic control during angioplasty revascularization for acute coronary syndrome ACS reduces circulating inflammatory cytokines and thrombus formation in hyperglycaemic patients Moreover the investigators will assess whether the tight glycemic control during the first month from coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI
Detailed Description:
The study design will be structured on the basis of protocol Yale Upon emergency wards admission all patients will be assigned to undergo prompt coronary revascularization After PCI procedures hyperglycemic patients will be randomly assigned to intensive glucose control IGC group and those treated with conventional glucose control CGC group In the patients with In the CGC group continuous insulin infusion of 50 IU Actrapid HM Novo Nordisk in 50 ml NaCl 09 using a Perfusor-FM pump will be started only when blood glucose levels exceeded 200 mgdl and adjusted to keep blood glucose between 180 and 200 mgdl When blood glucose fell 180 mgdl insulin infusion will be tapered and eventually stopped In the IGC group insulin infusion will be started when blood glucose levels exceeded 140 mgdl and adjusted to maintain glycemia at 80-140 mgdl During insulin infusion oral feeding will be stopped and parenteral nutrition 135 Kcalkg-1day-1 will be started After the start of insulin infusion protocol a glycemic control will be provided every hour in order to obtain three consecutive values that were within the goal range The infusion will be lasted until stable glycemic goal ICG group 80-140 mgdl CGC group 180-200 mgdl at least for 24 h After glycemic goal will be maintained for 24 h a parenteral nutrition was stopped and feeding will be started according to European guidelines Subcutaneous insulin will be initiated at the cessation of the infusion After discharge from the hospital insulin will be given as short-acting insulin before meals and long-acting insulin in the evening for 30 days from PCI in both group In IGC group the treatment goal will be a fasting blood glucose level of 90-140 mgdl and a non-fasting level of 180 mgdl In CGC group the treatment goal will be fasting blood glucose and postprandial levels of 200 mgdl With regard to the full medical therapy the protocol stated that the use of concomitant treatment should be as uniform as possible and according to evidence-based international guidelines for ACS After 30 days from PCI all patients with established diabetes and newly diagnosed diabetes will be managed and followed for 6 month after PCI as outpatients to maintain HbA1c 7 and blood glucose level of 90-140 mgdl and a non-fasting level of 180 mgdl
Coronary Angiography Coronary angiograms at baseline immediately after PCI and at 6 months will be performed in at least 2 orthogonal views after intracoronary nitroglycerin Minimum lumen diameter MLD and mean reference diameter RD obtained by averaging 5-mm segments proximal and distal to the target lesion location will be used to calculate diameter stenosis as follows 1-MLDRDX100 Late loss will the change in MLD from final PCI to follow-up In-stent analysis will be confined to the stent itself and in-segment analysis will be included the stent plus 5-mm segments proximal and distal to the stent Binary restenosis will be defined as a 50 diameter stenosis Qualitative analysis will be done with standard published methods
IVUS Imaging and Analysis IVUS at baseline immediately after PCI and at 6 months will be performed with iLab Galaxy and ClearView or In Vision Gold with 20-MHz EagleEye catheters IVUS imaging will be performed with motorized pullback at 05 mms to include the stent and 5 mm segments proximal and distal to the stent IVUS studies will be archived onto super-VHS tape CD-ROM or DVD and will be sent to an independent treatment-allocation- blinded IVUS core laboratory for quantitative and qualitative analyses with validated planimetry software Quantitative analysis will include measurement every 1 mm of the external elastic membrane EEM stent and lumen cross-sectional areas CSAs Plaque plus media CSA will be calculated as EEM minus lumen Neointimal hyperplasia NIH will be calculated as stent minus lumen Once a complete set of CSA measurements will be obtained intrastent and stent-edge volumes EEM plaque plus media stentlumen and NIH will be calculated with Simpsons rule and normalized for stent and reference segment length Percent net volume obstruction will be calculated as NIH divided by stent volume
Qualitative analysis will include stent malapposition blood speckle behind stent struts categorized as persistent visible both at baseline and follow-up resolved visible only at baseline and late acquired only visible at follow-up intrastent plaque andor thrombus protrusion IVUS cannot reliably differentiate between plaque and thrombus protruding through stent struts stent fracture absence of struts over more than one third of the stent circumference aneurysmlumen 50 larger than the proximal reference and edge dissection
Coronary Angiography Coronary angiograms at baseline immediately after PCI and at 6 months will be performed in at least 2 orthogonal views after intracoronary nitroglycerin Minimum lumen diameter MLD and mean reference diameter RD obtained by averaging 5-mm segments proximal and distal to the target lesion location will be used to calculate diameter stenosis as follows 1-MLDRDX100 Late loss will the change in MLD from final PCI to follow-up In-stent analysis will be confined to the stent itself and in-segment analysis will be included the stent plus 5-mm segments proximal and distal to the stent Binary restenosis will be defined as a 50 diameter stenosis Qualitative analysis will be done with standard published methods
IVUS Imaging and Analysis IVUS at baseline immediately after PCI and at 6 months will be performed with iLab Galaxy and ClearView or In Vision Gold with 20-MHz EagleEye catheters IVUS imaging will be performed with motorized pullback at 05 mms to include the stent and 5 mm segments proximal and distal to the stent IVUS studies will be archived onto super-VHS tape CD-ROM or DVD and will be sent to an independent treatment-allocation- blinded IVUS core laboratory for quantitative and qualitative analyses with validated planimetry software Quantitative analysis will include measurement every 1 mm of the external elastic membrane EEM stent and lumen cross-sectional areas CSAs Plaque plus media CSA will be calculated as EEM minus lumen Neointimal hyperplasia NIH will be calculated as stent minus lumen Once a complete set of CSA measurements will be obtained intrastent and stent-edge volumes EEM plaque plus media stentlumen and NIH will be calculated with Simpsons rule and normalized for stent and reference segment length Percent net volume obstruction will be calculated as NIH divided by stent volume
Qualitative analysis will include stent malapposition blood speckle behind stent struts categorized as persistent visible both at baseline and follow-up resolved visible only at baseline and late acquired only visible at follow-up intrastent plaque andor thrombus protrusion IVUS cannot reliably differentiate between plaque and thrombus protruding through stent struts stent fracture absence of struts over more than one third of the stent circumference aneurysmlumen 50 larger than the proximal reference and edge dissection
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