Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography

NCT02021188 | Completed

• 1 other identifier: A093095
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga- DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and quantification of vascular inflammation in the aorta, coronary and carotid arteries. This study will test the hypothesis that in subjects undergoing carotid endarterectomy for symptomatic plaques, there will be a positive correlation between carotid artery 68Ga-DOTATATE PET signal and the underlying degree of carotid inflammation measured by immunohistochemical analysis.

Conditions

Atherosclerosis; Stroke; Transient Ischemic Attack; Chronic Stable Angina; Acute Coronary Syndrome

Keywords

Vascular inflammation; Atherosclerosis; Positron Emission Tomography; Molecular Imaging; 68Ga-DOTATATE

Outcome Measures

Primary Outcomes (1)

• Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation

  This primary outcome 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.

  Baseline

Secondary Outcomes (5)

• Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques

  Baseline (<1 month from event)

• Correlation of carotid artery and coronary artery 68Ga-DOTATATE uptake

  Baseline

• Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake

  Baseline

• Correlation between carotid artery 68Ga-DOTATATE autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry

  Baseline

• Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake

  Baseline (2 scans within 1 week)

Study Arms (2)

Carotid artery disease

Participants with symptomatic or asymptomatic carotid artery plaques

Coronary artery disease

Participants with stable coronary artery disease or recent acute coronary syndrome

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit participants with recent transient ischaemic attack or stroke due to carotid artery disease, from which they have made a good functional recovery. A proportion of these patients will undergo carotid endarterectmy as part of clinical management. We will also recruit participants with asymptomatic carotid atheroma, and those with stable coronary artery disease or recent acute coronary syndrome.

You may qualify if:

• Age ≥40 years of age
• Can provide written, fully informed consent
• Have had a transient ischemic attack (TIA) or stroke within the preceding four weeks due to carotid artery atherosclerosis; or have ≥30% carotid artery or epicardial coronary artery stenosis

You may not qualify if:

• Renal impairment (eGFR\<30mls/min)
• History of contrast nephropathy
• Atrial fibrillation
• Any condition, in the opinion of the investigator, which prevents the participant from lying flat during scanning
• Women of childbearing potential
• Inability to provide written informed consent
• Haemorrhagic stroke within 3 months of study entry
• Total occlusion of a culprit carotid artery

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (2)

• Tarkin JM, Calcagno C, Dweck MR, Evans NR, Chowdhury MM, Gopalan D, Newby DE, Fayad ZA, Bennett MR, Rudd JHF. 68Ga-DOTATATE PET Identifies Residual Myocardial Inflammation and Bone Marrow Activation After Myocardial Infarction. J Am Coll Cardiol. 2019 May 21;73(19):2489-2491. doi: 10.1016/j.jacc.2019.02.052. No abstract available.

  PMID: 31097170 DERIVED

• Tarkin JM, Joshi FR, Evans NR, Chowdhury MM, Figg NL, Shah AV, Starks LT, Martin-Garrido A, Manavaki R, Yu E, Kuc RE, Grassi L, Kreuzhuber R, Kostadima MA, Frontini M, Kirkpatrick PJ, Coughlin PA, Gopalan D, Fryer TD, Buscombe JR, Groves AM, Ouwehand WH, Bennett MR, Warburton EA, Davenport AP, Rudd JH. Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060.

  PMID: 28385306 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Carotid artery plaques

MeSH Terms

Conditions

Atherosclerosis; Stroke; Ischemic Attack, Transient; Angina, Stable; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James HF Rudd, PhD, FRCP

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEFCE Senior Lecturer and Honorary Consultant Cardiologist

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 27, 2013
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

GB (1)