Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280976
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-02-05
Brief Title:
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque ART-CAP
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque ART-CAP
Status:
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:
ARTCAP
Brief Summary:
The purpose of this study is to evaluate the role of coronary CT angiogram CCTA as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes Participants aged 18-80 years at intermediate or high-risk for coronary artery disease with non-obstructive plaque on initial CCTA will be enrolled in this study They will be randomized into Standard of Care SOC vs Aggressive Therapy AT groups Both groups will undergo dietary and lifestyle interventions Follow-up will consist of blood tests and clinic visits at baseline 9 months and 18 months The second CCTA will be performed at 18 months to assess the change in plaque burden characteristics ischemia and pericoronaryepicardial fat
Detailed Description:
ART-CAP Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque is a prospective randomized open-label trial with blinded end-point This research project aims to study the role of coronary computed tomographic angiography CCTA as a superior guide for the direct assessment and monitoring of the impact of preventive cardiovascular drugs on coronary artery plaque for better clinical decision-making and improving patient outcomes Participants aged 18-80 years at intermediate or high-risk 10-year ASCVD risk of 5-20 or 20 calculated based on age gender race history of smoking diabetes mellitus hypertension hyperlipidemia and family history of premature CAD withwithout symptoms suggestive of coronary disease who has non-obstructive plaque on CCTA stenosis of 0-39 or 40-69 with FFR-CT 08 will be enrolled Participants with a history of heart attack coronary stents or bypass surgery recent stroke severe valvular heart disease pulmonary hypertension NYHA class 3 or 4 heart failure recent heart failure hospitalization active cancer life expectancy of 1 year end-stage kidney or liver disease pregnancy or uncontrolled psychiatric illness will be excluded
Participants will be randomly assigned to two groups - Standard of Care SOC 100 pts vs Aggressive Therapy AT 100 pts Both groups will receive dietary and lifestyle interventions SOC will be treated with statin andor aspirin as per the ACC guidelines AT group will be treated with statin aspirin nexlizet leqvio vascepa jardiance and colchicine Follow-up will consist of blood tests and clinic visits at baseline 9 months and 18 months At baseline participants will undergo Polygenic Risk Score PRS and next-generation sequencing NGS for a South Asian gene panel Biomarker evaluations at baseline 9 months and 18 months include lipid profiles inflammatory markers cardiac biomarkers and buffy coat analysis for CHIP along with standard blood tests including CBC and CMP Additionally echocardiographic evaluation will be performed at baseline and 18 months
After 18 months of medical treatment a repeat CCTA will be performed to evaluate primary endpoints of the percentage change in plaque burden total non-calcified and calcified plaque characteristics including high-risk features ischemia value for the most severe lesion and pericoronaryepicardial fat attenuation Patient will be followed for additional 5 years for MACCE major adverse cardiovascular and cerebrovascular events
Participants will be randomly assigned to two groups - Standard of Care SOC 100 pts vs Aggressive Therapy AT 100 pts Both groups will receive dietary and lifestyle interventions SOC will be treated with statin andor aspirin as per the ACC guidelines AT group will be treated with statin aspirin nexlizet leqvio vascepa jardiance and colchicine Follow-up will consist of blood tests and clinic visits at baseline 9 months and 18 months At baseline participants will undergo Polygenic Risk Score PRS and next-generation sequencing NGS for a South Asian gene panel Biomarker evaluations at baseline 9 months and 18 months include lipid profiles inflammatory markers cardiac biomarkers and buffy coat analysis for CHIP along with standard blood tests including CBC and CMP Additionally echocardiographic evaluation will be performed at baseline and 18 months
After 18 months of medical treatment a repeat CCTA will be performed to evaluate primary endpoints of the percentage change in plaque burden total non-calcified and calcified plaque characteristics including high-risk features ischemia value for the most severe lesion and pericoronaryepicardial fat attenuation Patient will be followed for additional 5 years for MACCE major adverse cardiovascular and cerebrovascular events
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