Novel Imaging Approaches To Identify Unstable Coronary Plaques

Coronary Artery Disease Clinical Trial

Official title:

Novel Imaging Approaches To Identify Unstable Coronary Plaques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749254
• Other study ID #: 2011/R/CAR/13
• Secondary ID: ETM/160
• Status: Completed
• Start date: February 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
United Kingdom	Clinical Research Imaging Centre/ NHS LOTHIAN	Edinburgh	Midlothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Joshi NV, Toor I, Shah AS, Carruthers K, Vesey AT, Alam SR, Sills A, Hoo TY, Melville AJ, Langlands SP, Jenkins WS, Uren NG, Mills NL, Fletcher AM, van Beek EJ, Rudd JH, Fox KA, Dweck MR, Newby DE. Systemic Atherosclerotic Inflammation Following Acute Myo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients	The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG	1 month
Other	Will patients with higher 18F-NaF uptake as measured by SUV/TBR will have higher levels of cardiac biomarkers such as hsCRP or Troponin	Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin	1 year
Primary	Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.	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.	Within 1 month of index event
Primary	What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value	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	1 month
Secondary	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