AtherosclerosisNCT01418313
Non-Invasive Imaging of Atherosclerosis
An observational study of Atherosclerosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI), dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for the detection and risk stratification of patients with atherosclerosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 886 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 9 Mar 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects in the New York area referred by primary care physician, or recruited through Lifeline Screening or ResearchMatch.org, or Mount Sinai Broadcast emails and flyers.
Who may be able to join
- Volunteers with carotid artery disease who are MRI and CT compatible.
- All subjects will have either a
- clinical diagnosis of atherosclerosis,
- and/or risk factors
- and/or family history of disease
Who cannot join
- Glomerular filtration rate <30mg/ml (for MRI with contrast)
- Subjects who have any ferromagnetic implants (e.g. aneurysm clip, ICD, pacemaker, etc.) or a condition that may be contraindicated for the MRI procedure (e.g. claustrophobia )
- Pregnant patients will be excluded from the present study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: In Vivo Molecular Imaging (MRI) of Atherothrombotic Lesions
The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI), dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for the detection and risk stratification of patients with atherosclerosis.
Read the detailed description
Atherosclerosis is responsible for the majority of disabilities and deaths in developed countries. Previous studies have shown that sudden clinical events correlate highly with plaque composition and the degree of plaque inflammation. These results stress the importance of developing non-invasive surrogate markers of plaque inflammation to detect asymptomatic high-risk plaques in clinical settings. Dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) and 18F fluorodeoxyglucose (FDG) positron emission tomography (PET) with combined computed tomography (CT) have shown promise in characterizing and quantifying metabolic activity (i.e., glycolysis/ inflammation) in atherosclerosis, by targeting the presence of neovessels (DCE-MRI) and inflammatory cells such as macrophages (18F-FDG PET) in plaques of both animal and human subjects. However, several challenges need to be overcome prior to translating these imaging approaches to clinical practice. A significant obstacle to adapting conventional DCE-MRI approaches to atherosclerosis includes the necessity to image with high spatial resolution to capture plaque heterogeneity. This can be achieved with longer scan times, but conflicts with need for high temporal resolution required for accurate arterial input function sampling and quantification of contrast agent uptake. In Aim 1, the investigators will develop and validate a novel dual-imaging sequence for DCE-MRI of atherosclerosis where the investigators acquire a high temporal resolution, but low spatial resolution, AIF image and a high spatial resolution/low temporal resolution vessel wall image to allow accurate quantification of contrast agent uptake within plaques. This approach will be compared to conventional approaches in both a rabbit model of atherosclerosis and in human subjects. The limited spatial resolution of conventional PET scanners has an impact on the accuracy of 18F-FDG PET quantification in atherosclerotic plaques because of the partial volume effect (PVE). A posteriori PVE correction methods using high-resolution anatomical images acquired with a different imaging modality can improve quantification, but are challenging since they require accurate co-registration between the another imaging modality and PET. MR is an ideal choice for this second imaging modality as it produces high-resolution anatomical images without the use of ionizing radiation. A combined MR/PET scanner may therefore be better suited for developing novel PVE correction methodologies. As part of Aim 2, the investigators will develop and validate the combined MR-PET(FDG) imaging approach to improve the quantification of atherosclerotic plaque metabolic activity. Attenuation correction based on MR will be compared with CT based attenuation correction. Approaches to improved PVE correction and optimal circulation time for plaque imaging will also be validated in both rabbits and humans. Finally, imaging parameters derived from the improved DCE-MRI and MR- PET(FDG) will be validated in patients undergoing carotid endarterectomy (CEA), with the primary endpoint of establishing the relationship between imaging and histological markers of plaque inflammation. Additionally, the investigators will assess the relationship (if any) with serum biomarkers and, as an exploratory endpoint, the investigators will study by real time PCR the relationship of imaging with the gene expression of markers of plaque vulnerability.
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis, Non-invasive imaging, Magnetic Resonance Imaging, MRI, Positron Emission Tomography, PET/CT, PET/MRI, Inflammation, Neovascularization
- Medical subject headings
- Atherosclerosis, Inflammation, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DCE-MRI | Magnetic resonance imaging (MRI) with and without FDA approved contrast agents: MRI is a non invasive imaging technique used to visualize the internal structure of the body in detail. The MRI machine is an oversized magnet that is always on. It will be used in this study to provide anatomical and functional (MRI with contrast) information about atherosclerotic plaques. | |
| PET/CT and PET/MR | Positron emission tomography (PET)/ computer tomography (CT): PET is a nuclear medicine imaging technique, which produces images of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. Nowadays PET imaging is most useful in combination with anatomical imaging, such as CT scanners, thereby PET scanners are now available with integrated high-end multi-detector row CT scanners. Because the two scans can be performed in immediate sequence during the same session and with the patient not changing position between the two scans, areas of abnormality on PET images can be directly correlated with anatomy on the CT images. | |
| PET/MR | Positron emission tomography (PET)/MRI: PET is a nuclear medicine imaging technique, which produces images of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. To avoid the additional radiation deriving from the CT scan during PET/CT imaging, nowadays PET imaging can be paired with MR anatomical images. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between imaging and biomarkers of atherosclerosis
R correlation coefficient
Measured: 5 years
Secondary outcomes (2)
DCE-MRI kinetic parameters
Parameters evaluating the uptake of MR contrast agent in atherosclerotic plaques. Kinetic parameters Ktrans (1/min) , ve (a.u.), vp (a.u.), Kep (1/min)
Measured: 3 years
FDG uptake parameters
Parameters evaluating the uptake of FDG in atherosclerotic plaques. Standardized uptake value (SUV) (a.u.); target to background ratio (TBR) (a.u.)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startSep 2011
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (139)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), NYU Langone Health
- Responsible party
- Principal investigator, Zahi Fayad, Icahn School of Medicine at Mount Sinai
- Investigators
- Zahi A Fayad, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418313
- Sponsor's protocol ID
- GCO 01-1032
- Other IDs
- R01HL071021
- Status last verified
- Jul 2020
- First submitted
- 5 Aug 2011
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Moustafa RR, Izquierdo-Garcia D, Fryer TD, Graves MJ, Rudd JH, Gillard JH, Weissberg PL, Baron JC, Warburton EA. Carotid plaque inflammation is associated with cerebral microembolism in patients with recent transient ischemic attack or stroke: a pilot study. Circ Cardiovasc Imaging. 2010 Sep;3(5):536-41. doi: 10.1161/CIRCIMAGING.110.938225. Epub 2010 Jul 16.
PubMed 20639303Rudd JH, Warburton EA, Fryer TD, Jones HA, Clark JC, Antoun N, Johnstrom P, Davenport AP, Kirkpatrick PJ, Arch BN, Pickard JD, Weissberg PL. Imaging atherosclerotic plaque inflammation with [18F]-fluorodeoxyglucose positron emission tomography. Circulation. 2002 Jun 11;105(23):2708-11. doi: 10.1161/01.cir.0000020548.60110.76.
PubMed 12057982Kwee RM, Teule GJ, van Oostenbrugge RJ, Mess WH, Prins MH, van der Geest RJ, Ter Berg JW, Franke CL, Korten AG, Meems BJ, Hofman PA, van Engelshoven JM, Wildberger JE, Kooi ME. Multimodality imaging of carotid artery plaques: 18F-fluoro-2-deoxyglucose positron emission tomography, computed tomography, and magnetic resonance imaging. Stroke. 2009 Dec;40(12):3718-24. doi: 10.1161/STROKEAHA.109.564088. Epub 2009 Oct 29.
PubMed 19875738Silvera SS, Aidi HE, Rudd JH, Mani V, Yang L, Farkouh M, Fuster V, Fayad ZA. Multimodality imaging of atherosclerotic plaque activity and composition using FDG-PET/CT and MRI in carotid and femoral arteries. Atherosclerosis. 2009 Nov;207(1):139-43. doi: 10.1016/j.atherosclerosis.2009.04.023. Epub 2009 Apr 24.
PubMed 19467659Nahrendorf M, Zhang H, Hembrador S, Panizzi P, Sosnovik DE, Aikawa E, Libby P, Swirski FK, Weissleder R. Nanoparticle PET-CT imaging of macrophages in inflammatory atherosclerosis. Circulation. 2008 Jan 22;117(3):379-87. doi: 10.1161/CIRCULATIONAHA.107.741181. Epub 2007 Dec 24.
PubMed 18158358Bertagna F, Bosio G, Caobelli F, Motta F, Biasiotto G, Giubbini R. Role of 18F-fluorodeoxyglucose positron emission tomography/computed tomography for therapy evaluation of patients with large-vessel vasculitis. Jpn J Radiol. 2010 Apr;28(3):199-204. doi: 10.1007/s11604-009-0408-2. Epub 2010 May 1.
PubMed 20437130Rogers IS, Nasir K, Figueroa AL, Cury RC, Hoffmann U, Vermylen DA, Brady TJ, Tawakol A. Feasibility of FDG imaging of the coronary arteries: comparison between acute coronary syndrome and stable angina. JACC Cardiovasc Imaging. 2010 Apr;3(4):388-97. doi: 10.1016/j.jcmg.2010.01.004.
PubMed 20394901Benedetto R, Carneiro MP, Junqueira FA, Coutinho A Jr, von Ristow A, Fonseca LM. (18)F-FDG in distinction of atherosclerotic plaque: Innovation in PET/MRI technology. Arq Bras Cardiol. 2009 Dec;93(6):e84-7, e97-100. doi: 10.1590/s0066-782x2009001200025. No abstract available. English, Portuguese.
PubMed 20379625Saam T, Rominger A, Wolpers S, Nikolaou K, Rist C, Greif M, Cumming P, Becker A, Foerster S, Reiser MF, Bartenstein P, Hacker M. Association of inflammation of the left anterior descending coronary artery with cardiovascular risk factors, plaque burden and pericardial fat volume: a PET/CT study. Eur J Nucl Med Mol Imaging. 2010 Jun;37(6):1203-12. doi: 10.1007/s00259-010-1432-2. Epub 2010 Mar 19.
PubMed 20300933Graebe M, Pedersen SF, Hojgaard L, Kjaer A, Sillesen H. 18FDG PET and ultrasound echolucency in carotid artery plaques. JACC Cardiovasc Imaging. 2010 Mar;3(3):289-95. doi: 10.1016/j.jcmg.2010.01.001.
PubMed 20223427Menezes LJ, Kayani I, Ben-Haim S, Hutton B, Ell PJ, Groves AM. What is the natural history of 18F-FDG uptake in arterial atheroma on PET/CT? Implications for imaging the vulnerable plaque. Atherosclerosis. 2010 Jul;211(1):136-40. doi: 10.1016/j.atherosclerosis.2010.01.012. Epub 2010 Jan 22.
PubMed 20202634Hays AG, Hirsch GA, Kelle S, Gerstenblith G, Weiss RG, Stuber M. Noninvasive visualization of coronary artery endothelial function in healthy subjects and in patients with coronary artery disease. J Am Coll Cardiol. 2010 Nov 9;56(20):1657-65. doi: 10.1016/j.jacc.2010.06.036.
PubMed 21050976Balu N, Wang J, Dong L, Baluyot F, Chen H, Yuan C. Current techniques for MR imaging of atherosclerosis. Top Magn Reson Imaging. 2009 Aug;20(4):203-15. doi: 10.1097/RMR.0b013e3181ea287d.
PubMed 20805731Muntendam P, McCall C, Sanz J, Falk E, Fuster V; High-Risk Plaque Initiative. The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. Am Heart J. 2010 Jul;160(1):49-57.e1. doi: 10.1016/j.ahj.2010.02.021.
PubMed 20598972Li F, McDermott MM, Li D, Carroll TJ, Hippe DS, Kramer CM, Fan Z, Zhao X, Hatsukami TS, Chu B, Wang J, Yuan C. The association of lesion eccentricity with plaque morphology and components in the superficial femoral artery: a high-spatial-resolution, multi-contrast weighted CMR study. J Cardiovasc Magn Reson. 2010 Jul 1;12(1):37. doi: 10.1186/1532-429X-12-37.
PubMed 20591197
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Molecular Imaging (MRI) of Atherothrombotic Lesions
- ClinicalTrials.gov ID
- NCT01418313
- Acronym / sponsor ID
- GCO 01-1032
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis, Non-invasive imaging, Magnetic Resonance Imaging, MRI, Positron Emission Tomography, PET/CT, PET/MRI, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), NYU Langone Health
- Study start
- Sep 2011
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 17 Aug 2011 (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.
The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI), dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for the detection and risk stratification of patients with atherosclerosis.
Detailed description
Atherosclerosis is responsible for the majority of disabilities and deaths in developed countries. Previous studies have shown that sudden clinical events correlate highly with plaque composition and the degree of plaque inflammation. These results stress the importance of developing non-invasive surrogate markers of plaque inflammation to detect asymptomatic high-risk plaques in clinical settings. Dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) and 18F fluorodeoxyglucose (FDG) positron emission tomography (PET) with combined computed tomography (CT) have shown promise in characterizing and quantifying metabolic activity (i.e., glycolysis/ inflammation) in atherosclerosis, by targeting the presence of neovessels (DCE-MRI) and inflammatory cells such as macrophages (18F-FDG PET) in plaques of both animal and human subjects. However, several challenges need to be overcome prior to translating these imaging approaches to clinical practice. A significant obstacle to adapting conventional DCE-MRI approaches to atherosclerosis includes the necessity to image with high spatial resolution to capture plaque heterogeneity. This can be achieved with longer scan times, but conflicts with need for high temporal resolution required for accurate arterial input function sampling and quantification of contrast agent uptake. In Aim 1, the investigators will develop and validate a novel dual-imaging sequence for DCE-MRI of atherosclerosis where the investigators acquire a high temporal resolution, but low spatial resolution, AIF image and a high spatial resolution/low temporal resolution vessel wall image to allow accurate quantification of contrast agent uptake within plaques. This approach will be compared to conventional approaches in both a rabbit model of atherosclerosis and in human subjects. The limited spatial resolution of conventional PET scanners has an impact on the accuracy of 18F-FDG PET quantification in atherosclerotic plaques because of the partial volume effect (PVE). A posteriori PVE correction methods using high-resolution anatomical images acquired with a different imaging modality can improve quantification, but are challenging since they require accurate co-registration between the another imaging modality and PET. MR is an ideal choice for this second imaging modality as it produces high-resolution anatomical images without the use of ionizing radiation. A combined MR/PET scanner may therefore be better suited for developing novel PVE correction methodologies. As part of Aim 2, the investigators will develop and validate the combined MR-PET(FDG) imaging approach to improve the quantification of atherosclerotic plaque metabolic activity. Attenuation correction based on MR will be compared with CT based attenuation correction. Approaches to improved PVE correction and optimal circulation time for plaque imaging will also be validated in both rabbits and humans. Finally, imaging parameters derived from the improved DCE-MRI and MR- PET(FDG) will be validated in patients undergoing carotid endarterectomy (CEA), with the primary endpoint of establishing the relationship between imaging and histological markers of plaque inflammation. Additionally, the investigators will assess the relationship (if any) with serum biomarkers and, as an exploratory endpoint, the investigators will study by real time PCR the relationship of imaging with the gene expression of markers of plaque vulnerability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DCE-MRI | – | –Magnetic resonance imaging (MRI) with and without FDA approved contrast agents: MRI is a non invasive imaging technique used to visualize the internal structure of the body in detail. The MRI machine is an oversized magnet that is always on. It will be used in this study to provide anatomical and functional (MRI with contrast) information about atherosclerotic plaques. |
| PET/CT and PET/MR | – | –Positron emission tomography (PET)/ computer tomography (CT): PET is a nuclear medicine imaging technique, which produces images of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. Nowadays PET imaging is most useful in combination with anatomical imaging, such as CT scanners, thereby PET scanners are now available with integrated high-end multi-detector row CT scanners. Because the two scans can be performed in immediate sequence during the same session and with the patient not changing position between the two scans, areas of abnormality on PET images can be directly correlated with anatomy on the CT images. |
| PET/MR | – | –Positron emission tomography (PET)/MRI: PET is a nuclear medicine imaging technique, which produces images of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. To avoid the additional radiation deriving from the CT scan during PET/CT imaging, nowadays PET imaging can be paired with MR anatomical images. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in the New York area referred by primary care physician, or recruited through Lifeline Screening or ResearchMatch.org, or Mount Sinai Broadcast emails and flyers.
Key inclusion criteria (5 listed)
- Volunteers with carotid artery disease who are MRI and CT compatible.
- All subjects will have either a
Key exclusion criteria (3 listed)
- Glomerular filtration rate <30mg/ml (for MRI with contrast)
- Subjects who have any ferromagnetic implants (e.g. aneurysm clip, ICD, pacemaker, etc.) or a condition that may be contraindicated for the MRI procedure (e.g. claustrophobia )
- Pregnant patients will be excluded from the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between imaging and biomarkers of atherosclerosis
Time frame: 5 years
R correlation coefficient
2 secondary outcomes
DCE-MRI kinetic parameters
Time frame: 3 years
FDG uptake parameters
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Background: PubMed 20639303Moustafa RR, Izquierdo-Garcia D, Fryer TD, Graves MJ, Rudd JH, Gillard JH, Weissberg PL, Baron JC, Warburton EA. Carotid plaque inflammation is associated with cerebral microembolism in patients with recent transient ischemic attack or stroke: a pilot study. Circ Cardiovasc Imaging. 2010 Sep;3(5):536-41. doi: 10.1161/CIRCIMAGING.110.938225. Epub 2010 Jul 16.
- Background: PubMed 12057982Rudd JH, Warburton EA, Fryer TD, Jones HA, Clark JC, Antoun N, Johnstrom P, Davenport AP, Kirkpatrick PJ, Arch BN, Pickard JD, Weissberg PL. Imaging atherosclerotic plaque inflammation with [18F]-fluorodeoxyglucose positron emission tomography. Circulation. 2002 Jun 11;105(23):2708-11. doi: 10.1161/01.cir.0000020548.60110.76.
- Background: PubMed 19875738Kwee RM, Teule GJ, van Oostenbrugge RJ, Mess WH, Prins MH, van der Geest RJ, Ter Berg JW, Franke CL, Korten AG, Meems BJ, Hofman PA, van Engelshoven JM, Wildberger JE, Kooi ME. Multimodality imaging of carotid artery plaques: 18F-fluoro-2-deoxyglucose positron emission tomography, computed tomography, and magnetic resonance imaging. Stroke. 2009 Dec;40(12):3718-24. doi: 10.1161/STROKEAHA.109.564088. Epub 2009 Oct 29.
- Background: PubMed 19467659Silvera SS, Aidi HE, Rudd JH, Mani V, Yang L, Farkouh M, Fuster V, Fayad ZA. Multimodality imaging of atherosclerotic plaque activity and composition using FDG-PET/CT and MRI in carotid and femoral arteries. Atherosclerosis. 2009 Nov;207(1):139-43. doi: 10.1016/j.atherosclerosis.2009.04.023. Epub 2009 Apr 24.
- Background: PubMed 18158358Nahrendorf M, Zhang H, Hembrador S, Panizzi P, Sosnovik DE, Aikawa E, Libby P, Swirski FK, Weissleder R. Nanoparticle PET-CT imaging of macrophages in inflammatory atherosclerosis. Circulation. 2008 Jan 22;117(3):379-87. doi: 10.1161/CIRCULATIONAHA.107.741181. Epub 2007 Dec 24.
- Background: PubMed 20437130Bertagna F, Bosio G, Caobelli F, Motta F, Biasiotto G, Giubbini R. Role of 18F-fluorodeoxyglucose positron emission tomography/computed tomography for therapy evaluation of patients with large-vessel vasculitis. Jpn J Radiol. 2010 Apr;28(3):199-204. doi: 10.1007/s11604-009-0408-2. Epub 2010 May 1.
- Background: PubMed 20394901Rogers IS, Nasir K, Figueroa AL, Cury RC, Hoffmann U, Vermylen DA, Brady TJ, Tawakol A. Feasibility of FDG imaging of the coronary arteries: comparison between acute coronary syndrome and stable angina. JACC Cardiovasc Imaging. 2010 Apr;3(4):388-97. doi: 10.1016/j.jcmg.2010.01.004.
- Background: PubMed 20379625Benedetto R, Carneiro MP, Junqueira FA, Coutinho A Jr, von Ristow A, Fonseca LM. (18)F-FDG in distinction of atherosclerotic plaque: Innovation in PET/MRI technology. Arq Bras Cardiol. 2009 Dec;93(6):e84-7, e97-100. doi: 10.1590/s0066-782x2009001200025. No abstract available. English, Portuguese.
- Background: PubMed 20300933Saam T, Rominger A, Wolpers S, Nikolaou K, Rist C, Greif M, Cumming P, Becker A, Foerster S, Reiser MF, Bartenstein P, Hacker M. Association of inflammation of the left anterior descending coronary artery with cardiovascular risk factors, plaque burden and pericardial fat volume: a PET/CT study. Eur J Nucl Med Mol Imaging. 2010 Jun;37(6):1203-12. doi: 10.1007/s00259-010-1432-2. Epub 2010 Mar 19.
- Background: PubMed 20223427Graebe M, Pedersen SF, Hojgaard L, Kjaer A, Sillesen H. 18FDG PET and ultrasound echolucency in carotid artery plaques. JACC Cardiovasc Imaging. 2010 Mar;3(3):289-95. doi: 10.1016/j.jcmg.2010.01.001.
- Background: PubMed 20202634Menezes LJ, Kayani I, Ben-Haim S, Hutton B, Ell PJ, Groves AM. What is the natural history of 18F-FDG uptake in arterial atheroma on PET/CT? Implications for imaging the vulnerable plaque. Atherosclerosis. 2010 Jul;211(1):136-40. doi: 10.1016/j.atherosclerosis.2010.01.012. Epub 2010 Jan 22.
- Background: PubMed 21050976Hays AG, Hirsch GA, Kelle S, Gerstenblith G, Weiss RG, Stuber M. Noninvasive visualization of coronary artery endothelial function in healthy subjects and in patients with coronary artery disease. J Am Coll Cardiol. 2010 Nov 9;56(20):1657-65. doi: 10.1016/j.jacc.2010.06.036.
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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.
Zahi A Fayad, PhD principal investigator
Icahn School of Medicine at Mount Sinai
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 Atherosclerosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 3 Aug 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between imaging and biomarkers of atherosclerosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418313, which also lists 139 linked publications.
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 3 Aug 2020.