Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05427084
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2022-06-01
Brief Title:
Canagliflozin Targeting Vascular Inflammation
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Canagliflozin Targeting Vascular Inflammation An Ottawa Imaging Study - A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
CANTORSING
Brief Summary:
CANTOR SING is a pilot single center double blinded randomized study The investigators will compare the effect of canagliflozin 300 mg daily - intervention arm vs placebo control group on the FDG aortic uptake in patients with stable CAD over 60 days post-myocardial infarction after a 6-month period of treatment The investigators plan to enroll 8 patients in each arm total sample size 16 patients Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm
Detailed Description:
CANTOR SING is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using canagliflozin on aortic inflammation using imaging ie ascending aortic FDG uptake The current proposal uses a randomized design to evaluate the effect of canagliflozin vs placebo on aortic inflammation activity over 6 months measured using FDG PET
At the University of Ottawa Heart Institute UOHI patients with diabetes and stable CAD defined as patients over 60 days post-myocardial infarction will be recruited
Patients who meet inclusionexclusion criteria will undergo clinical evaluation FDG PET imaging with contrast-CT and blood sample collection HbA1C Fasting Blood Sugar FBS lipids C-reactive protein CRP creatinine CR glomerular filtration rate GFR complete blood count CBC hemoglobin liver function tests - AST ALT creatine kinase CK will be collected from the patients clinical data or if not available may be collected as part of the study
Patients recruited into the CANTOR SING study will be randomized to receive either an oral canagliflozin 300 mg capsule or placebo capsule administered once daily for 6 months Patients will take the medication for 6 months The study will be conducted in a double-blinded fashion
Patients will be followed up every 3 months for the 6-month evaluation period Clinical evaluation and blood collection for labs CBC electrolytes CPK ALT AST creatinine will performed at baseline and will be repeated every 3 months for a a total of 6 months of follow-up FDG PET imaging with contrast-CT will be repeated at 6 months Finally blood will be collected at baseline and 6 months
At the University of Ottawa Heart Institute UOHI patients with diabetes and stable CAD defined as patients over 60 days post-myocardial infarction will be recruited
Patients who meet inclusionexclusion criteria will undergo clinical evaluation FDG PET imaging with contrast-CT and blood sample collection HbA1C Fasting Blood Sugar FBS lipids C-reactive protein CRP creatinine CR glomerular filtration rate GFR complete blood count CBC hemoglobin liver function tests - AST ALT creatine kinase CK will be collected from the patients clinical data or if not available may be collected as part of the study
Patients recruited into the CANTOR SING study will be randomized to receive either an oral canagliflozin 300 mg capsule or placebo capsule administered once daily for 6 months Patients will take the medication for 6 months The study will be conducted in a double-blinded fashion
Patients will be followed up every 3 months for the 6-month evaluation period Clinical evaluation and blood collection for labs CBC electrolytes CPK ALT AST creatinine will performed at baseline and will be repeated every 3 months for a a total of 6 months of follow-up FDG PET imaging with contrast-CT will be repeated at 6 months Finally blood will be collected at baseline and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None