PET/CT for the Quantification of Atherosclerotic Plaque Inflammation
QAEK
1 other identifier
observational
140
1 country
1
Brief Summary
This is a single-centre prospective trial with 140 patients employing \[18F\]-fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) and advance motion correction and image fusion algorithms to create motion frozen displays and quantify FDG-uptake and thus inflammatory activity in atherosclerotic plaques in the coronary tree. Four groups of patients, two with stable coronary artery disease and two with acute coronary syndrome will be compared and the results of FDG PET/CT will be correlated to results of invasive coronary angiography, intravascular ultrasound / virtual histology, patient risk profile and serum markers of inflammation. The investigators hypothesize that increased FDG accumulation in atherosclerotic plaques shows a positive correlation with inflammatory activity in coronary plaques and markers of plaque vulnerability as well as the risk profile of the patients and serum markers of inflammation. The investigators furthermore hypothesize that FDG PET/CT is able to detect high risk patients and provide an important means for risk stratification and optimization of patient management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 14, 2012
March 1, 2012
2 years
March 10, 2012
March 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Association of FDG uptake and coronary plaque vulnerability
Increased FDG uptake is found in plaques that fulfill the criteria of plaque vulnerability as measured with IVUS/VH.
within 72 hours after enrollment
Secondary Outcomes (3)
Association of FDG-uptake and extent of the disease
within 72 hours after enrollment
Association of FDG-uptake and risk profile / serum markers
within 72 hours after enrollment
Association of FDG-uptake and cardiovascular events
within 1 year of follow-up
Study Arms (4)
Group 1 - STEMI
Patients with acute cardiovascular event and typical aberrations in the ECG(STEMI) and positive serum markers
Group 2 - NSTEMI
Patients with acute coronary syndrome without typical aberrations in the ECG (NSTEMI) or without positive serum markers
Group 3 - symptomatic CAD
Symptomatic patients with stable CAD, who are eligible for ICA
Group 4 - STEMI
Patients eligible for ICA 6 months after STEMI and revascularization
Interventions
Patients will receive 20 mg furosemide and 20 mg butylscopolamine together with 370 MBq FDG. 120 minutes after the FDG application a ECG- and respiratory gated cardial PET acquisition will be performed, followed by a CT calcium scan, which will also be used for attenuation correction. This will be followed by CT-angiography with the application of 80 ml contrast medium. Patients without betablocker and a heart rate of more than 70 / min will be treated with 50 - 100 mg metoprolol as long as there are no contraindications. Subsequently, a 3D-mode whole body PET scan will be acquired followed by a low-dose CT transmission scan from the base of the scull to the iliac crest.
ICA is performed via the femoral artery in three projections (RAO 30°, RAO 15° and LAO 45°) and, if necessary, also in further projections. All angiograms are recorded digitally and assessed quantitatively by two experienced readers, who are blinded to the PET/CT results (Quant-Cor, QCA, Siemens Medical Systems, Forchheim, Germany or Digital Cardiac Imaging Systems, Philips, Eindhoven, Netherlands). The mean stenosis of the vessel is assessed in two projections and the percentage of stenosis is calculated for each single segment. Stenoses are localized by means of the AHA (American Heart Association) classification. Occlusions of the vessels are documented and revascularization is performed immediately in patients with acute coronary syndrome (STEMI, NSTEMI).
During the procedure an intravascular ultrasound will be recorded in grayscale. Radiofrequency raw-data will be collected at the peak of the R-wave and a VH-IVUS data recorder is used to reconstruct a color-coded map. Acquired data will be evaluated with a dedicated software. The grayscale IVUS images will be analyzed frame by frame and used to measure the diameter of the vessel lumen, of the external elastic membrane (EEM) as well as plaque and media thickness (defined as EEM minus lumen). The plaque burden will be calculated. A VH-IVUS analysis will be performed for each frame. Four plaque components will be color-coded: dense calcium white, the necrotic core red, fatty tissue light green and scar tissue dark green. color fractions are expressed as percentage of the plaque area and percentage of plaque volume. Lesions will be classified: pathologic intima thickening, fibroatheroma with thin cap, fibroatheroma with thick cap, fibrotic plaque and fibro-calcified plaque.
A 20 ml blood sample will be obtained from each patient. The following biomarkers will be assessed: glucose level, HBA1C, cholesterol levels, LDL cholesterol, HDL cholesterol, triglycerides, fibrinogen, factor XIII, plasminogen, complement C3, TNF-alpha, IL-6, CRP, resistin, adiponectin, CD40, 5-lipoxygenase, MMP-9, MMP-1, osteopontin, osteoprotegerin, fetuin, FGF21. ELISA and/or calorimetric assays will be used for the biochemical analyses of the serum markers.
Eligibility Criteria
Patients with stable coronary artery disease or with acute coronary syndrome
You may qualify if:
- symptomatic patients with known STEMI or NSTEMI and/or known CAD (see patient groups above)
- written informed consent for blood samples, ICA, IVUS/VH and FDG PET/CT
You may not qualify if:
- less than 50 years of age
- reason for symptoms other than coronary stenoses / occlusion
- known contraindication for the above listed examinations (like iodine allergy, intolerance of contrast media, claustrophobia)
- patients, who are not able to lie still without changing position over a minimum of 45 minutes
- pregnancy, breast feeding
- restricted renal function (creatinine \> 1,5 mg% in women, \> 2mg% in men)
- surgery within prior 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nuclear Medicine, Departmen of Cardiology, University of Munich
Munich, Bavaria, 81377, Germany
Biospecimen
A 20 ml blood sample will be obtained from each patient. The following biomarkers will be assessed: glucose level, HBA1C, cholesterol levels, LDL cholesterol, HDL cholesterol, triglycerides, fibrinogen, factor XIII, plasminogen, complement C3, TNF-alpha, IL-6, CRP, resistin, adiponectin, CD40, 5-lipoxygenase, MMP-9, MMP-1, osteopontin, osteoprotegerin, fetuin, FGF21. ELISA and/or calorimetric assays will be used for the biochemical analyses of the serum markers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Hacker, MD
LMU Munich
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med. Marcus Hacker
Study Record Dates
First Submitted
March 10, 2012
First Posted
March 14, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
March 14, 2012
Record last verified: 2012-03