The VISION study: vascular inflammation imaging using somatostatin receptor positron emission tomography

Not Applicable

Completed

Conditions: Circulatory System
Subtopic: Cardiovascular (all Subtopics)
Disease: Cardiovascular
Topic: Cardiovascular disease

Registration Number: ISRCTN34560142

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

Subjects with carotid artery disease:
Symptomatic subjects: 20
1. Age =40 years of age
2. Can provide written, fully informed consent
3. Have had a TIA or stroke within the preceding 4 weeks thought to be due to carotid artery atherosclerosis

Asymptomatic subjects: 10
1. Age =40 years of age
2. Can provide written, fully informed consent
3. Have at least a 30% stenosis in the carotid artery (control cohort)

Subjects with coronary artery disease:
Symptomatic and asymptomatic subjects: 20 total
1. Aged at least 40 years of age
2. Can provide written, fully informed consent
3. Have at least a 30% stenosis in =1 epicardial artery

Exclusion Criteria

1. Renal impairment (eGFR <30 ml/min)
2. History of contrast nephropathy
3. Atrial fibrillation
4. Any condition, in the opinion of the investigator, which prevents the participant from lying flat during scanning
5. Women of childbearing potential
6. Inability to provide written informed consent
7. Haemorrhagic stroke within 3 months of study entry
8. Total occlusion of a culprit carotid artery
9. Any medical condition, vital sign or laboratory value that, in the opinion of the investigator, makes the subject ineligible for inclusion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation (time frame: baseline). This measure is correlation between carotid artery 68Ga-DOTATATE PET signal (TBR) and the underlying degree of carotid inflammation, measured by CD68 immunohistochemistry, in patients undergoing carotid endarterectomy.

Secondary Outcome Measures