Skip to main content
OpenTrials
Completed

NCT Number: NCT01749254

Novel Imaging Approaches To Identify Unstable Coronary Plaques

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Imaging Centre/ NHS LOTHIAN

Edinburgh, Midlothian, EH16 4SB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.

    Time frame: 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.

  2. What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value

    Time frame: 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

Secondary outcomes

  1. 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.

    Time frame: 1 month

Other outcomes

  1. Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients

    Time frame: 1 month

    The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG

  2. Will patients with higher 18F-NaF uptake as measured by SUV/TBR will have higher levels of cardiac biomarkers such as hsCRP or Troponin

    Time frame: 1 year

    Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • University of Cambridge

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2012
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.