Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606821
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
The Effects of Tirzepatide in People with Overweightobesity and Coronary Artery Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Tirzepatide on Coronary Plaque Lipid Content and Myocardial Microvascular Function in Overweight and Obese People with Coronary Disease - the IDEAL-COR Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL-COR
Brief Summary:
The objective of this study is to investigate as a proof-of-principle long-term 52 weeks effects of tirzepatide once-weekly vs placebo on changes in coronary plaque composition and progression assessed by NIRS plaque burden assessed by IVUS and microvascular function assessed by invasively measured CFR in overweight and obese individuals with stable coronary artery disease CAD In addition the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular CV predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects
Detailed Description:
The anti-atherogenic effect of tirzepatide has been studied in preclinical studies and seems to involve mechanisms related to a reduction in vascular inflammation and lipid accumulation Any direct anti-atherogenic effect of tirzepatide may potentially reduce the incidence of major cardiovascular endpoints in individuals with overweight or obesity As a proof of principle it would be of scientific and clinical interest to explore the anti-atherogenic effect of tirzepatide in humans IVUS-NIRS imaging is uniquely suited for this purpose as it makes it possible to detect changes in not only atheroma burden by IVUS but also to detect progression within the plaques in the lipidicnecrotic core component by NIRS LCBItotal allows for consecutive detection of small changes in the same individual which is pivotal to explore the supposed antiatherogenic mechanism of tirzepatide with enough statistical power
The investigators hypothesize that once-weekly sc tirzepatide can reduce coronary lipid accumulation in the arterial wall and the progression of atheromatosis in individuals with overweight or obesity and established high-risk atherosclerosis The investigators aim to investigate this hypothesis in a proof-of-principle study by investigating the change in coronary plaque composition in individuals with overweight or obesity and coronary artery disease CAD with high-risk characteristics by NIRS imaging randomised to 52-week treatment with tirzepatide or placebo
The investigators hypothesize that once-weekly sc tirzepatide can reduce coronary lipid accumulation in the arterial wall and the progression of atheromatosis in individuals with overweight or obesity and established high-risk atherosclerosis The investigators aim to investigate this hypothesis in a proof-of-principle study by investigating the change in coronary plaque composition in individuals with overweight or obesity and coronary artery disease CAD with high-risk characteristics by NIRS imaging randomised to 52-week treatment with tirzepatide or placebo
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