Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049 | Recruiting

• 2 other identifiers: AC25008BHF PG/24/12097
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with symptomatic peripheral arterial disease.

Conditions

Peripheral Arterial Disease; Chronic Limb Threatening Ischemia

Keywords

Peripheral arterial disease; Chronic limb threatening ischaemia; PET-CT; cardiovascular diseases; Sodium Fluoride; GP1; DOTATATE

Outcome Measures

Primary Outcomes (1)

• Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)

  The 3 primary endpoints will be the location and degree of: 1. inflammation: uptake of \[68Ga\]DOTATATE 2. calcification: uptake of \[18F\]NaF 3. thrombus activity: uptake of \[18F\]GP1 in peripheral arterial disease affecting the lower limbs. This will be determined by the degree of tracer standardised uptake values (SUVs) at the site of the symptomatic atherosclerotic plaque.

  From baseline imaging until completion imaging at 1 year

Secondary Outcomes (4)

• Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories

  From baseline imaging until completion imaging at 1 year

• CT plaque morphology

  From baseline imaging to completion imaging at 1 year

• The association between patient risk factors for cardiovascular disease and PET tracer uptake

  Frome baseline imaging to completion imaging at 1 year

• The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification.

  From baseline imaging to completion imaging at 1 year

Other Outcomes (1)

• Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)

  From baseline imaging to completion imaging at 1 year

Study Arms (1)

Patients with symptomatic peripheral arterial disease

Radiation: Whole body [68Ga]DOTATATE PET-CT; Radiation: Whole body [18F]GP1 PET-CT; Radiation: Whole body [18F]NaF PET-CT; Radiation: Whole body CT angiogram

Interventions

Whole body [68Ga]DOTATATE PET-CT RADIATION

Targeting vascular inflammation

Patients with symptomatic peripheral arterial disease

Whole body [18F]GP1 PET-CT RADIATION

Targeting thrombus activity

Patients with symptomatic peripheral arterial disease

Whole body [18F]NaF PET-CT RADIATION

Targeting vascular microcalcification

Patients with symptomatic peripheral arterial disease

Whole body CT angiogram RADIATION

To determine anatomical and morphological atherosclerotic plaque characteristics

Patients with symptomatic peripheral arterial disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.

You may qualify if:

• Male or female aged \> 18 years
• Symptomatic atherosclerotic peripheral artery disease;
• Intermittent claudication; with ankle/arm blood pressure ratio \<0.90 or artery stenosis \>50% in addition to at least one of the following;
• \>1 vascular bed affected by atherosclerosis
• Diabetes
• Heart failure
• Chronic kidney disease (eGFR \< 60 mL/min/1.73 m2)
• Rest pain or necrosis of limb or gangrene of limb
• Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery
• Leg or foot amputation for arterial vascular indications
• Ability to give written or verbal informed consent

You may not qualify if:

• Contraindication to colchicine or iodinated contrast
• Long term requirement for colchicine for another clinical indication
• Active diarrhoea
• Recent lower limb revascularisation for symptomatic disease (\<6 weeks)
• Renal failure (glomerular filtration rate \<30 mL/min/1.73 m2)
• Cirrhosis or severe chronic liver disease
• Women who are pregnant or breast-feeding
• Women of child-bearing potential not protected by reliable contraception or is planning conception during the study
• Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (apart from azithromycin)
• Patients deemed unlikely to return for follow up
• Life expectancy \<1 year
• Inability or unwilling to give informed consent

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

If patients undergo arterial surgery as part of their routine clinical care, consent is sought to retain explanted tissue. Blood samples will also be obtained.

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison c Winarski, MBChB, MRCS(Ed)

CONTACT

+447495905258; awinarsk@ed.ac.uk

Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)

CONTACT

+44 01312423585; rachael.forsythe@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: March 16, 2026
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)