Atherosclerosis Clinical Trial
Official title:
PET Imaging of Inflammation and Lipid Lowering Study
While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.
Up-regulation of SST2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68Ga-DOTATATE. To test the hypothesis that 68Ga-DOTATATE can quantify drug-induced changes in arterial inflammation, patients with primary hypercholesterolaemia (non-familial or familial) or mixed dyslipidaemia with stable cardiovascular Disease (CVD) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies will undergo carotid artery 68Ga-DOTATATE PET-magnetic resonance imaging (MRI) in a randomised, double-blind, placebo-controlled study of inclisiran or colchicine. In parallel, we will examine a novel method for detecting plaque composition based on analysis of ultrasound centre frequency shifts, which was developed by collaborators in Lund University, Sweden. The Ultrasound Plaque Structure Analysis (UPSA) method uses radiofrequency algorithms to create real-time tissue-like maps of carotid plaques. Participants in the study will undergo carotid ultrasound imaging using the UPSA method in addition to PET/MRI. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05052918 -
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
|
N/A | |
Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
Recruiting |
NCT06230406 -
T-Mem GEne in Atherosclerosis
|
||
Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|
||
Completed |
NCT03393377 -
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
|
N/A | |
Completed |
NCT02224339 -
New Technologies to Determine Carotid Plaque Vulnerability
|
||
Completed |
NCT02268513 -
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
|
||
Completed |
NCT02116829 -
Is There Room for Butter in a Healthy Diet?
|
N/A | |
Not yet recruiting |
NCT01923012 -
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
|
Phase 2 |