Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05152888
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2021-11-29
Brief Title:
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
The Impact of Pcsk-9 Inhibition on PET Coronary Flow Reserve in Patients at High Cardiovascular Risk EMPOWER Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
EMPOWER
Brief Summary:
The study protocol is a single-arm open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic andor from the BWH Nuclear Cardiology Laboratory A target sample size of 50 participants will undergo imaging with N-13 ammonia or Rubidium-82 positron emission tomography PET and coronary computed tomography angiography CCTA before and after 12 months of PCSK-9 inhibition with Evolocumab to assess changes in myocardial blood flow and plaque volume To help account for physiological changes that may occur in myocardial blood flow and inflammatory biomarkers during the study period we will also recruit a parallel control group of stable CAD patients who will undergo similar baseline and 12-month imaging and biomarker assessment We plan to recruit 15 patients in the parallel control group
Detailed Description:
The investigators propose an open-label investigator-initiated trial to directly test whether PCSK-9 inhibition with Evolocumab in patients with stable CAD improves PET CFR and stress MBF To further elucidate the possible mechanisms by which myocardial blood flow improves with PCSK-9 inhibition the investigators will assess changes in inflammatory biomarkers The findings of this translational study will provide a physiological read-out of the comprehensive effects of Evolocumab on tissue perfusion and microvascular function in a high-risk population As such these data would serve to provide a mechanistic explanation for why Evolocumab may reduce cardiovascular events beyond a reduction in plaque burden and composition
The central hypothesis of this study is that PCSK-9 inhibition will quantitatively improve myocardial blood flow as measured by positron emission tomography PET in patients with stable coronary artery disease The investigators postulate that the improvement in myocardial blood flow will correlate with a reduction in inflammatory biomarkers and not simply an improvement in coronary epicardial plaque burden
The central hypothesis of this study is that PCSK-9 inhibition will quantitatively improve myocardial blood flow as measured by positron emission tomography PET in patients with stable coronary artery disease The investigators postulate that the improvement in myocardial blood flow will correlate with a reduction in inflammatory biomarkers and not simply an improvement in coronary epicardial plaque burden
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None