Novel Imaging Approaches To Identify Unstable Coronary Plaques

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01749254
• Lead Sponsor: University of Edinburgh

Brief Summary

Cardiovascular disease is the leading cause of death in Scotland and the Western World. Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic plaques are urgently needed to help risk stratification, to identify patients for intensive therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug interventions. Using positron emission tomography, we have recently shown that sodium 18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture. Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and unstable coronary artery disease. This has the potential to provide an innovative and highly valuable translational model with which to test novel therapeutic interventions targeted at reducing atheroma and plaque rupture. This could have major implications for the future treatment of cardiovascular disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age > or = 50 yrs. Patients with Acute coronary syndromes or stable coronary artery disease.

Exclusion Criteria

Insulin dependent diabetes Inability or unwillingness to undergo computed tomography scanning Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min) Known contrast allergy Inability to give informed consent. Females in child bearing age will undergo pregnancy test if pregnancy suspected.

Participation in other research studies requiring exposure to further radiation (over and above mentioned in this study).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value	1 month	Using VH-IVUS, the investigators will look at the morphological characteristics of plaques that have higher SUVs and TBRs. Additional information about the plaque characteristics will be derived from CT coronary angiogram
Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.	Within 1 month of index event	Using PET/CT, the investigators will assess if there is presence of focal uptake at the areas of plaque ruptures in patients presenting with ACS. Standardised uptake values and Tissue to Background ratios of the culprit vessels with be compared with non-culprit lesions.

Secondary Outcome Measures

Name	Time	Method
Is there a co-relation between the two PET/CT tracers(18FDG and 18F NaF) as measured as Tissue to background ratio or standardised uptake value.	1 month

Trial Locations

Locations (1)

Clinical Research Imaging Centre/ NHS LOTHIAN; 🇬🇧 Edinburgh, Midlothian, United Kingdom