Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04559191
Status:
UNKNOWN
Last Update Posted:
2020-09-22
First Post:
2020-09-02
Brief Title:
Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring
Sponsor:
National Cerebral and Cardiovascular Center Japan
Organization:
National Cerebral and Cardiovascular Center Japan
Study Overview
Official Title:
The Efficacy of Glycemic Control With Continuous Glucose Monitoring on Atheroma Progression Rationale and Design of the Observation of Coronary Atheroma Progression Under Continuous Glucose Monitoring Guidance in Patients With Type 2 Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
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:
OPTIMAL
Brief Summary:
The OPTIMAL is a single-center randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound IVUS and near-infrared spectroscopy NIRS imaging A total of 90 eligible subjects will be randomized 11 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management Coronary angiography and NIRSIVUS imaging is repeated at the end of the assigned treatment period
Results The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months The secondary endpoints include 1 the absolute change in percent atheroma volume 2 the percent change in lipid core burden index 3 the change in coefficient variance measured by CGM 4 the change in atherogenic markers high-density lipoprotein functionality proprotein convertase subxilisinkexin type 9 and fatty-acid binding proteins and 5 the frequency of hypoglycemia Safety will also be evaluated
Results The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months The secondary endpoints include 1 the absolute change in percent atheroma volume 2 the percent change in lipid core burden index 3 the change in coefficient variance measured by CGM 4 the change in atherogenic markers high-density lipoprotein functionality proprotein convertase subxilisinkexin type 9 and fatty-acid binding proteins and 5 the frequency of hypoglycemia Safety will also be evaluated
Detailed Description:
Enrollment of 90 patients is planned at National Cerebral Cardiovascular Center in Japan Study participants are randomly assigned to either CGM-based glucose management or HbA1c-based glucose management
Eligible subjects should have CAD requiring elective PCI HbA1c at screening should be between 70 and 100
Non-culprit vessel with its severe tortuousty andor calcification will be excluded Subjects with baseline estimated glomerular filtration rate 40 mLmin173m2 will not be eligible
After informed consent has been obtained elective PCI will be conducted to treat culprit lesion NIRSIVUS imaging will be conducted to evaluate coronary atheroma
In the CGM-based glucose management group CGM FreeStyle Libre Pro Abbott Chicago Illinoi the United States and HbA1c measurement will be undertaken at baseline and 3 6 9 and 12 months following PCI In the HbA1c-based glucose management group HbA1c will be measured at baseline and 3 6 9 and 12 months after PCI and CGM will be used at baseline and 12 months in a similar fashion
With regard to the use of anti-diabetic drugs in the CGM-guided glycemic control group endocrinologist will select glucose lowering drugs to fulfill the following CGM-derived goals a the frequency of hypoglycemia0 b the coefficient of variation 36 and c averaged glucose level between 70-180 mgdl6 If the frequency of hypoglycemia is over 10 andor the averaged glucose level is more than 400 mgdl patients will be asked to visit within 1 month after CGM measurement In the HbA1c-guided therapy group the selection of glucose lowering agents will be made according to the discretion of each endocrinologist to achieve HbA1c 70
At 12 months following PCI patients will be hospitalized to take follow-up coronary angiography and intravascular imaging study NIRSIVUS imaging in the non-culprit vessel will be conducted again in a similar fashion
Eligible subjects should have CAD requiring elective PCI HbA1c at screening should be between 70 and 100
Non-culprit vessel with its severe tortuousty andor calcification will be excluded Subjects with baseline estimated glomerular filtration rate 40 mLmin173m2 will not be eligible
After informed consent has been obtained elective PCI will be conducted to treat culprit lesion NIRSIVUS imaging will be conducted to evaluate coronary atheroma
In the CGM-based glucose management group CGM FreeStyle Libre Pro Abbott Chicago Illinoi the United States and HbA1c measurement will be undertaken at baseline and 3 6 9 and 12 months following PCI In the HbA1c-based glucose management group HbA1c will be measured at baseline and 3 6 9 and 12 months after PCI and CGM will be used at baseline and 12 months in a similar fashion
With regard to the use of anti-diabetic drugs in the CGM-guided glycemic control group endocrinologist will select glucose lowering drugs to fulfill the following CGM-derived goals a the frequency of hypoglycemia0 b the coefficient of variation 36 and c averaged glucose level between 70-180 mgdl6 If the frequency of hypoglycemia is over 10 andor the averaged glucose level is more than 400 mgdl patients will be asked to visit within 1 month after CGM measurement In the HbA1c-guided therapy group the selection of glucose lowering agents will be made according to the discretion of each endocrinologist to achieve HbA1c 70
At 12 months following PCI patients will be hospitalized to take follow-up coronary angiography and intravascular imaging study NIRSIVUS imaging in the non-culprit vessel will be conducted again in a similar fashion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None