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PET Imaging of Inflammation and Lipid Lowering Study

ConditionsHypercholesterolemiaHypercholesterolemia, FamilialAtherosclerosisCarotid Artery Plaque
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Cambridge

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants >18 years old

Able to give written, informed consent and to lie flat

Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia (HeFH) based on clinical criteria) or mixed dyslipidaemia, and

History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral arterial disease) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies (see NICE TA 733), and

Disqualifiers

Women of childbearing potential not using adequate contraception

Contra-indication to MRI scanning

Statin-associated myositis or liver function abnormality

Already taking inclisiran or colchicine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inclisiran

    Drug

    Inclisiran 284 mg, one injection

  • 68Ga-DOTATATE PET-MRI

    Diagnostic test

    68Ga-DOTATATE PET-MRI at baseline and 12 weeks

  • Colchicine

    Drug

    Colchicine 500 mcg tablet once daily

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: Stable CVD - treatmentExperimental treatment 2 interventions
Group B: Stable CVD - placebo controlActive comparator 2 interventions
Group C: HeFH - treatmentPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Carotid 68Ga-DOTATATE PET

Relative change from baseline in carotid artery 68Ga-DOTATATE tissue-to-blood ratio in the index vessel

Time frame
12 weeks
2

Carotid UPSA imaging

Relative change from baseline in carotid artery UPSA signal in the index vessel

Time frame
12 weeks

Secondary outcomes

1

MRI plaque burden

Relative change from baseline in carotid artery total plaque burden and lipid-rich necrotic core measured by MRI

Time frame
12 weeks
2

Carotid 68Ga-DOTATATE vs. serum lipids

Comparison of carotid 68Ga-DOTATATE imaging to serum lipids

Time frame
12 weeks
3

Carotid 68Ga-DOTATATE vs. hsCRP

Comparison of carotid 68Ga-DOTATATE imaging to high-sensitivity C-reactive protein (hsCRP)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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University of Cambridge

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborator

Wellcome Trust

Collaborator

GE Healthcare

Collaborator

Lund University

Collaborator

Source ClinicalTrials.gov
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