Coronary Artery DiseaseQAEKNCT01553513
PET/CT for the Quantification of Atherosclerotic Plaque Inflammation
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- [18F]-FDG positron emission computed tomography, Invasive coronary angiography and Intravascular ultrasound and virtual histology
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable coronary artery disease or with acute coronary syndrome
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Nuclear Medicine, Departmen of Cardiology, University of Munich
Munich, Bavaria, 81377
Marcus Hacker, MD, +49 (0)89 7095 4646, marcus.hacker@med.uni-muenchen.de
Sebastian Lehner, MD, +49 (0)89 7095 4646, sebastian.lehner@med.uni-muenchen.de
About this study
Official title: PET/CT for the Quantification of Atherosclerotic Plaque Inflammation in Patients With Coronary Heart Disease: The QAEK Trial
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.
Read the detailed description
Currently there are only morphological reference standards to detect vulnerable coronary plaques. However, inflammatory activity and plaque composition predict future cardiovascular events. Thus the aims and objectives of the study are the following:
- Inflammatory activity of the coronary arteries and the great peripheral arteries shall be detected and quantified by means of FDG PET/CT hybrid imaging.
- We aim to develop "motion frozen displays" of the heart and coronary arteries by means of ECG- and respiratory triggering of myocardial motion to reduce motion artifacts.
- We aim to compare the coronary FDG uptake of patients with known stable CAD to the coronary FDG uptake of patients with acute coronary syndrome.
- We aim to correlate coronary PET/CT with intravascular ultrasound (IVUS) / virtual histology (VH), which will be carried out during coronary angiography and provides the gold standard to characterize plaque composition.
- Correlation of the inflammatory activity as measured by PET with the risk profile of the patients, blood coagulability and inflammatory and plaque-associated serum markers to establish a valid risk stratification.
- Follow-up of the patients over at least one year to detect cardiovascular events.
Study Design
This is a prospective single-center study to evaluate coronary FDG PET/CT under controlled and standardized conditions. The study was approved by the local ethical committee as well as the German Federal Authority for Radiation Protection (Bundesamt für Strahlenschutz). All examinations will be performed at the University Hospital of the LMU in Munich. The study is in accordance with the Declaration of Helsinki, all patients provide informed written consent.
We plan to image four study populations with a high risk for inflammatory atherosclerosis or plaque rupture: two groups consist of patients with stable coronary disease and two groups consist of patients with acute coronary syndrome (Figure 1).
In the following, these groups will be described in more detail.
Patients with acute coronary syndrome Group 1: Patients with acute cardiovascular event and typical aberrations in the ECG (STEMI) and positive serum markers need to be stabilized immediately, thus they are not eligible for IVUS. However, by means of ICA the "culprit lesion" can be identified. 48 to 72 hours after the event the stable patients will receive FDG PET/CT to detect morphology and inflammation of the culprit lesion as well as further vulnerable plaques that might need intervention. PET/CT results will be correlated with results of ICA.
Group 2: Patients with acute coronary syndrome without typical aberrations in the ECG (NSTEMI) or without positive serum markers need to be stabilized immediately. In a second step ICA and IVUS / VH will be performed. 48 to 72 hours after the event the stable patients will receive FDG PET/CT to detect morphology and inflammation of the culprit lesion as well as further vulnerable plaques that might need intervention. PET/CT results will be correlated with results of ICA and IVUS / VH.
Patients with stable CAD Group 3: Symptomatic patients with stable CAD, who are eligible for ICA will receive and additional FDG PET/CT scan as well as IVUS / VH. Results will be correlated.
Group 4: Patients eligible for ICA 6 months after STEMI and revascularization will receive IVUS / VH and FDG PET/CT. Results will be correlated with regard to the former culprit lesion as well as further coronary lesions that might be present.
Summary of working hypotheses
Hypothesis 1 (technique) By means of FDG PET/CT the radiotracer uptake in the coronary arteries can be allocated to specific lesions and quantified with the aid of appropriate techniques for motion correction and three-dimensional image fusion.
Hypothesis 2 (association of FDG-uptake and extent of the disease) The coronary FDG-uptake of patients with stable CAD is significantly lower than the coronary FDG-uptake of patients with acute coronary syndrome.
Hypothesis 3 (correlation between IVUS/VH and FDG-uptake) Plaques with typical signs of vulnerability in IVUS/VH show a significantly increased FDG-uptake as a surrogate marker of inflammatory activity.
Hypothesis 4 (association of FDG-uptake and risk profile / serum markers) Coronary FDG-uptake shows a positive correlation with increasing risk profile (Framingham Score) and serum markers for plaque vulnerability and inflammatory reactions.
Hypothesis 5 (association of FDG-uptake and cardiovascular events) Increased coronary FDG-uptake and increased uptake in the peripheral vessels are associated with cardiovascular and cerebrovascular events over the course of one year.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- [18F]-FDG positron emission computed tomography, Invasive coronary angiography, Intravascular ultrasound and virtual histology, Serum biomarkers
- Keywords
- PET, Coronary Artery Disease, Inflammation, Plaque, Atherosclerosis
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Inflammation, Plaque, Amyloid, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FDG positron emission computed tomographyOther
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.
Invasive coronary angiographyProcedure or surgery
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).
Intravascular ultrasound and virtual histologyProcedure or surgery
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.
Serum biomarkersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - STEMI | Patients with acute cardiovascular event and typical aberrations in the ECG(STEMI) and positive serum markers Receives: Other: [18F]-FDG positron emission computed tomography; Procedure: Invasive coronary angiography; Other: Serum biomarkers | |
| Group 2 - NSTEMI | Patients with acute coronary syndrome without typical aberrations in the ECG (NSTEMI) or without positive serum markers Receives: Other: [18F]-FDG positron emission computed tomography; Procedure: Invasive coronary angiography; Procedure: Intravascular ultrasound and virtual histology; Other: Serum biomarkers | |
| Group 3 - symptomatic CAD | Symptomatic patients with stable CAD, who are eligible for ICA Receives: Other: [18F]-FDG positron emission computed tomography; Procedure: Invasive coronary angiography; Procedure: Intravascular ultrasound and virtual histology; Other: Serum biomarkers | |
| Group 4 - STEMI | Patients eligible for ICA 6 months after STEMI and revascularization Receives: Other: [18F]-FDG positron emission computed tomography; Procedure: Invasive coronary angiography; Procedure: Intravascular ultrasound and virtual histology; Other: Serum biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 72 hours after enrollment
Secondary outcomes (3)
Association of FDG-uptake and extent of the disease
The coronary FDG-uptake of patients with stable CAD is significantly lower than the coronary FDG-uptake of patients with acute coronary syndrome.
Measured: within 72 hours after enrollment
Association of FDG-uptake and risk profile / serum markers
Coronary FDG-uptake shows a positive correlation with increasing risk profile(Framingham Score) and serum markers for plaque vulnerability and inflammatory reactions.
Measured: within 72 hours after enrollment
Association of FDG-uptake and cardiovascular events
Increased coronary FDG-uptake and increased uptake in the peripherial vessels are associated with cardiovascular and cerebrovascular events over the course of one year.
Measured: within 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. M. Hacker, Ludwig-Maximilians - University of Munich
- Investigators
- Marcus Hacker, MD, Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553513
- Sponsor's protocol ID
- LMU
- Acronym
- QAEK
- Status last verified
- Mar 2012
- First submitted
- 10 Mar 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT for the Quantification of Atherosclerotic Plaque Inflammation in Patients With Coronary Heart Disease: The QAEK Trial
- ClinicalTrials.gov ID
- NCT01553513
- Acronym / sponsor ID
- QAEK / LMU
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- PET, Coronary Artery Disease, Inflammation, Plaque, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently there are only morphological reference standards to detect vulnerable coronary plaques. However, inflammatory activity and plaque composition predict future cardiovascular events. Thus the aims and objectives of the study are the following:
- Inflammatory activity of the coronary arteries and the great peripheral arteries shall be detected and quantified by means of FDG PET/CT hybrid imaging.
- We aim to develop "motion frozen displays" of the heart and coronary arteries by means of ECG- and respiratory triggering of myocardial motion to reduce motion artifacts.
- We aim to compare the coronary FDG uptake of patients with known stable CAD to the coronary FDG uptake of patients with acute coronary syndrome.
- We aim to correlate coronary PET/CT with intravascular ultrasound (IVUS) / virtual histology (VH), which will be carried out during coronary angiography and provides the gold standard to characterize plaque composition.
- Correlation of the inflammatory activity as measured by PET with the risk profile of the patients, blood coagulability and inflammatory and plaque-associated serum markers to establish a valid risk stratification.
- Follow-up of the patients over at least one year to detect cardiovascular events.
Study Design
This is a prospective single-center study to evaluate coronary FDG PET/CT under controlled and standardized conditions. The study was approved by the local ethical committee as well as the German Federal Authority for Radiation Protection (Bundesamt für Strahlenschutz). All examinations will be performed at the University Hospital of the LMU in Munich. The study is in accordance with the Declaration of Helsinki, all patients provide informed written consent.
We plan to image four study populations with a high risk for inflammatory atherosclerosis or plaque rupture: two groups consist of patients with stable coronary disease and two groups consist of patients with acute coronary syndrome (Figure 1).
In the following, these groups will be described in more detail.
Patients with acute coronary syndrome Group 1: Patients with acute cardiovascular event and typical aberrations in the ECG (STEMI) and positive serum markers need to be stabilized immediately, thus they are not eligible for IVUS. However, by means of ICA the "culprit lesion" can be identified. 48 to 72 hours after the event the stable patients will receive FDG PET/CT to detect morphology and inflammation of the culprit lesion as well as further vulnerable plaques that might need intervention. PET/CT results will be correlated with results of ICA.
Group 2: Patients with acute coronary syndrome without typical aberrations in the ECG (NSTEMI) or without positive serum markers need to be stabilized immediately. In a second step ICA and IVUS / VH will be performed. 48 to 72 hours after the event the stable patients will receive FDG PET/CT to detect morphology and inflammation of the culprit lesion as well as further vulnerable plaques that might need intervention. PET/CT results will be correlated with results of ICA and IVUS / VH.
Patients with stable CAD Group 3: Symptomatic patients with stable CAD, who are eligible for ICA will receive and additional FDG PET/CT scan as well as IVUS / VH. Results will be correlated.
Group 4: Patients eligible for ICA 6 months after STEMI and revascularization will receive IVUS / VH and FDG PET/CT. Results will be correlated with regard to the former culprit lesion as well as further coronary lesions that might be present.
Summary of working hypotheses
Hypothesis 1 (technique) By means of FDG PET/CT the radiotracer uptake in the coronary arteries can be allocated to specific lesions and quantified with the aid of appropriate techniques for motion correction and three-dimensional image fusion.
Hypothesis 2 (association of FDG-uptake and extent of the disease) The coronary FDG-uptake of patients with stable CAD is significantly lower than the coronary FDG-uptake of patients with acute coronary syndrome.
Hypothesis 3 (correlation between IVUS/VH and FDG-uptake) Plaques with typical signs of vulnerability in IVUS/VH show a significantly increased FDG-uptake as a surrogate marker of inflammatory activity.
Hypothesis 4 (association of FDG-uptake and risk profile / serum markers) Coronary FDG-uptake shows a positive correlation with increasing risk profile (Framingham Score) and serum markers for plaque vulnerability and inflammatory reactions.
Hypothesis 5 (association of FDG-uptake and cardiovascular events) Increased coronary FDG-uptake and increased uptake in the peripheral vessels are associated with cardiovascular and cerebrovascular events over the course of one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - STEMI | – | Other: [18F]-FDG positron emission computed tomography, Procedure: Invasive coronary angiography, Other: Serum biomarkersPatients with acute cardiovascular event and typical aberrations in the ECG(STEMI) and positive serum markers |
| Group 2 - NSTEMI | – | Other: [18F]-FDG positron emission computed tomography, Procedure: Invasive coronary angiography, Procedure: Intravascular ultrasound and virtual histology, Other: Serum biomarkersPatients with acute coronary syndrome without typical aberrations in the ECG (NSTEMI) or without positive serum markers |
| Group 3 - symptomatic CAD | – | Other: [18F]-FDG positron emission computed tomography, Procedure: Invasive coronary angiography, Procedure: Intravascular ultrasound and virtual histology, Other: Serum biomarkersSymptomatic patients with stable CAD, who are eligible for ICA |
| Group 4 - STEMI | – | Other: [18F]-FDG positron emission computed tomography, Procedure: Invasive coronary angiography, Procedure: Intravascular ultrasound and virtual histology, Other: Serum biomarkersPatients eligible for ICA 6 months after STEMI and revascularization |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary artery disease or with acute coronary syndrome
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-FDG positron emission computed tomographyPatients 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. | Other | Group 1 - STEMI, Group 2 - NSTEMI, Group 3 - symptomatic CAD, Group 4 - STEMI |
| Invasive coronary angiographyICA 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). | Procedure or surgery | Group 1 - STEMI, Group 2 - NSTEMI, Group 3 - symptomatic CAD, Group 4 - STEMI |
| Intravascular ultrasound and virtual histologyDuring 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. | Procedure or surgery | Group 2 - NSTEMI, Group 3 - symptomatic CAD, Group 4 - STEMI |
| Serum biomarkersA 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. | Other | Group 1 - STEMI, Group 2 - NSTEMI, Group 3 - symptomatic CAD, Group 4 - STEMI |
Primary outcome
Association of FDG uptake and coronary plaque vulnerability
Time frame: within 72 hours after enrollment
Increased FDG uptake is found in plaques that fulfill the criteria of plaque vulnerability as measured with IVUS/VH.
3 secondary outcomes
Association of FDG-uptake and extent of the disease
Time frame: within 72 hours after enrollment
Association of FDG-uptake and risk profile / serum markers
Time frame: within 72 hours after enrollment
Association of FDG-uptake and cardiovascular events
Time frame: within 1 year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Hacker, MD principal investigator
LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Hacker, MD (+49 (0)89 7095 4646, marcus.hacker@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of FDG uptake and coronary plaque vulnerability (time frame: within 72 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.