Novel Imaging Approaches To Identify Unstable Coronary Plaques

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Edinburgh
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01749254
First received: November 30, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Novel Imaging Approaches To Identify Unstable Coronary Plaques

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG

  • 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 ] [ Designated as safety issue: No ]
    Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Coronary Syndrome
40 patients admitted with ACS (NSTEMI/STEMI) will be recruited undergo 18F NaF PET, 18F FDG and CTCA within 1 month of the event.
Stable angina cohort
40 patients with previously diagnosed coronary artery disease and listed to undergo elective coronary angiogram will be recruited. VH-IVUS will be attempted in all patients. Selected patients will undergo PET scan after stent implantation.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The investigators will recruit two populations of 40 patients each. The first population will be patients with known stable coronary heart disease. They will have previously documented and angiographically proven coronary artery disease (≥70% luminal stenosis of a major epicardial vessel). The second population will be patients with a recent (within 30 days) acute myocardial infarction defined by the Universal definition of myocardial infarction. The culprit plaque will be defined according to the invasive coronary angiogram appearances, electrocardiogram and clinical features by two cardiologists blinded to the results of positron emission tomography.

Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749254

Locations
United Kingdom
Clinical Research Imaging Centre/ NHS LOTHIAN Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Contact: DAVID NEWBY, MD PHD    0131 242 6515    d.e.newby@ed.ac.uk   
Principal Investigator: Nikhil Joshi, MD         
Sponsors and Collaborators
University of Edinburgh
University of Cambridge
  More Information

Additional Information:
No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01749254     History of Changes
Other Study ID Numbers: 2011/R/CAR/13, ETM/160
Study First Received: November 30, 2012
Last Updated: December 11, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Edinburgh:
Culprit plaques
Vulnerable Plaques
PET
calcification
inflammation

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014