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Rationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography

dal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is... Full description

Journal Title: The American heart journal 2011, Vol.162 (2), p.214-221.e2
Main Author: Fayad, Zahi A., PhD
Other Authors: Mani, Venkatesh, PhD , Woodward, Mark, PhD , Kallend, David, MB, BS , Bansilal, Sameer, MD, MSc , Pozza, Joseph, RN, BSN , Burgess, Tracy, MSc , Fuster, Valentin, MD, PhD , Rudd, James H.F., MD, PhD, MRCP (UK) , Tawakol, Ahmed, MD , Farkouh, Michael E., MD, MSc
Format: Electronic Article Electronic Article
Language: English
Subjects:
NMR
Quelle: Alma/SFX Local Collection
Publisher: New York, NY: Mosby, Inc
ID: ISSN: 0002-8703
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title: Rationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography
format: Article
creator:
  • Fayad, Zahi A., PhD
  • Mani, Venkatesh, PhD
  • Woodward, Mark, PhD
  • Kallend, David, MB, BS
  • Bansilal, Sameer, MD, MSc
  • Pozza, Joseph, RN, BSN
  • Burgess, Tracy, MSc
  • Fuster, Valentin, MD, PhD
  • Rudd, James H.F., MD, PhD, MRCP (UK)
  • Tawakol, Ahmed, MD
  • Farkouh, Michael E., MD, MSc
subjects:
  • Adolescent
  • Adult
  • Aged
  • Amides
  • Anticholesteremic Agents - administration & dosage
  • Anticholesteremic Agents - therapeutic use
  • Article
  • Atherosclerosis
  • Atherosclerosis (general aspects, experimental research)
  • Biological and medical sciences
  • Blood and lymphatic vessels
  • Blood pressure
  • Cardiac patients
  • Cardiology. Vascular system
  • Cardiovascular
  • Cardiovascular disease
  • Cholesterol
  • Clinical medicine
  • Coronary Disease - diagnosis
  • Coronary Disease - drug therapy
  • Coronary heart disease
  • Diabetes
  • Diagnosis, Differential
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug dosages
  • Drugs
  • Esters
  • Family medical history
  • Female
  • Fluorodeoxyglucose F18
  • Follow-Up Studies
  • Humans
  • Hypotheses
  • Lipids
  • Magnetic Resonance Imaging - methods
  • Male
  • Medical sciences
  • Middle Aged
  • Mortality
  • NMR
  • Nuclear magnetic resonance
  • Plaque, Atherosclerotic - diagnosis
  • Plaque, Atherosclerotic - drug therapy
  • Positron-Emission Tomography - methods
  • Radiopharmaceuticals
  • Retrospective Studies
  • Risk Factors
  • Statins
  • Sulfhydryl Compounds - administration & dosage
  • Sulfhydryl Compounds - therapeutic use
  • Tomography
  • Tomography, X-Ray Computed - methods
  • Treatment Outcome
  • Triglycerides
  • Young Adult
ispartof: The American heart journal, 2011, Vol.162 (2), p.214-221.e2
description: dal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is linked to increased risk of coronary heart disease (CHD). Dalcetrapib, a compound that increases high-density lipoprotein cholesterol by modulating cholesteryl ester transfer protein, is being studied to assess if it can reduce the progression of atherosclerotic disease and thereby decrease cardiovascular morbidity and mortality. Patients with CHD or CHD-risk equivalents were randomized to receive 600 mg dalcetrapib or placebo daily for 24 months, in addition to conventional lipid-lowering medication and other medications for cardiovascular risk factors. The primary outcomes are the effect of dalcetrapib on 18F-fluorodeoxyglucose positron emission tomography target-to-background ratio after 6 months and magnetic resonance imaging (MRI) plaque burden (wall area, wall thickness, total vessel area, and wall area/total vessel area ratio) after 12 months. Secondary objectives include positron emission tomography target-to-background ratio at 3 months and MRI plaque burden at 6 and 24 months; plaque composition at 6, 12, and 24 months; and aortic compliance at 6 months. A tertiary objective is to examine the dynamic contrast-enhanced MRI parameters of plaque neovascularization. In total, 189 subjects entered screening, and 130 were randomized. dal-PLAQUE will provide important information on the effects of dalcetrapib on markers of inflammation and atherosclerotic plaque burden and, thereby, on the safety of cholesteryl ester transfer protein modulation with dalcetrapib. Results are expected in 2011.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-8703
fulltext: fulltext
issn:
  • 0002-8703
  • 1097-6744
url: Link


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titleRationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography
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creatorFayad, Zahi A., PhD ; Mani, Venkatesh, PhD ; Woodward, Mark, PhD ; Kallend, David, MB, BS ; Bansilal, Sameer, MD, MSc ; Pozza, Joseph, RN, BSN ; Burgess, Tracy, MSc ; Fuster, Valentin, MD, PhD ; Rudd, James H.F., MD, PhD, MRCP (UK) ; Tawakol, Ahmed, MD ; Farkouh, Michael E., MD, MSc
creatorcontribFayad, Zahi A., PhD ; Mani, Venkatesh, PhD ; Woodward, Mark, PhD ; Kallend, David, MB, BS ; Bansilal, Sameer, MD, MSc ; Pozza, Joseph, RN, BSN ; Burgess, Tracy, MSc ; Fuster, Valentin, MD, PhD ; Rudd, James H.F., MD, PhD, MRCP (UK) ; Tawakol, Ahmed, MD ; Farkouh, Michael E., MD, MSc
descriptiondal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is linked to increased risk of coronary heart disease (CHD). Dalcetrapib, a compound that increases high-density lipoprotein cholesterol by modulating cholesteryl ester transfer protein, is being studied to assess if it can reduce the progression of atherosclerotic disease and thereby decrease cardiovascular morbidity and mortality. Patients with CHD or CHD-risk equivalents were randomized to receive 600 mg dalcetrapib or placebo daily for 24 months, in addition to conventional lipid-lowering medication and other medications for cardiovascular risk factors. The primary outcomes are the effect of dalcetrapib on 18F-fluorodeoxyglucose positron emission tomography target-to-background ratio after 6 months and magnetic resonance imaging (MRI) plaque burden (wall area, wall thickness, total vessel area, and wall area/total vessel area ratio) after 12 months. Secondary objectives include positron emission tomography target-to-background ratio at 3 months and MRI plaque burden at 6 and 24 months; plaque composition at 6, 12, and 24 months; and aortic compliance at 6 months. A tertiary objective is to examine the dynamic contrast-enhanced MRI parameters of plaque neovascularization. In total, 189 subjects entered screening, and 130 were randomized. dal-PLAQUE will provide important information on the effects of dalcetrapib on markers of inflammation and atherosclerotic plaque burden and, thereby, on the safety of cholesteryl ester transfer protein modulation with dalcetrapib. Results are expected in 2011.
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languageeng
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subjectAdolescent ; Adult ; Aged ; Amides ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - therapeutic use ; Article ; Atherosclerosis ; Atherosclerosis (general aspects, experimental research) ; Biological and medical sciences ; Blood and lymphatic vessels ; Blood pressure ; Cardiac patients ; Cardiology. Vascular system ; Cardiovascular ; Cardiovascular disease ; Cholesterol ; Clinical medicine ; Coronary Disease - diagnosis ; Coronary Disease - drug therapy ; Coronary heart disease ; Diabetes ; Diagnosis, Differential ; Disease Progression ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug dosages ; Drugs ; Esters ; Family medical history ; Female ; Fluorodeoxyglucose F18 ; Follow-Up Studies ; Humans ; Hypotheses ; Lipids ; Magnetic Resonance Imaging - methods ; Male ; Medical sciences ; Middle Aged ; Mortality ; NMR ; Nuclear magnetic resonance ; Plaque, Atherosclerotic - diagnosis ; Plaque, Atherosclerotic - drug therapy ; Positron-Emission Tomography - methods ; Radiopharmaceuticals ; Retrospective Studies ; Risk Factors ; Statins ; Sulfhydryl Compounds - administration & dosage ; Sulfhydryl Compounds - therapeutic use ; Tomography ; Tomography, X-Ray Computed - methods ; Treatment Outcome ; Triglycerides ; Young Adult
ispartofThe American heart journal, 2011, Vol.162 (2), p.214-221.e2
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0Rationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography
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descriptiondal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is linked to increased risk of coronary heart disease (CHD). Dalcetrapib, a compound that increases high-density lipoprotein cholesterol by modulating cholesteryl ester transfer protein, is being studied to assess if it can reduce the progression of atherosclerotic disease and thereby decrease cardiovascular morbidity and mortality. Patients with CHD or CHD-risk equivalents were randomized to receive 600 mg dalcetrapib or placebo daily for 24 months, in addition to conventional lipid-lowering medication and other medications for cardiovascular risk factors. The primary outcomes are the effect of dalcetrapib on 18F-fluorodeoxyglucose positron emission tomography target-to-background ratio after 6 months and magnetic resonance imaging (MRI) plaque burden (wall area, wall thickness, total vessel area, and wall area/total vessel area ratio) after 12 months. Secondary objectives include positron emission tomography target-to-background ratio at 3 months and MRI plaque burden at 6 and 24 months; plaque composition at 6, 12, and 24 months; and aortic compliance at 6 months. A tertiary objective is to examine the dynamic contrast-enhanced MRI parameters of plaque neovascularization. In total, 189 subjects entered screening, and 130 were randomized. dal-PLAQUE will provide important information on the effects of dalcetrapib on markers of inflammation and atherosclerotic plaque burden and, thereby, on the safety of cholesteryl ester transfer protein modulation with dalcetrapib. Results are expected in 2011.
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10Blood and lymphatic vessels
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12Cardiac patients
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15Cardiovascular disease
16Cholesterol
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19Coronary Disease - drug therapy
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21Diabetes
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24Dose-Response Relationship, Drug
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46Radiopharmaceuticals
47Retrospective Studies
48Risk Factors
49Statins
50Sulfhydryl Compounds - administration & dosage
51Sulfhydryl Compounds - therapeutic use
52Tomography
53Tomography, X-Ray Computed - methods
54Treatment Outcome
55Triglycerides
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titleRationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography
authorFayad, Zahi A., PhD ; Mani, Venkatesh, PhD ; Woodward, Mark, PhD ; Kallend, David, MB, BS ; Bansilal, Sameer, MD, MSc ; Pozza, Joseph, RN, BSN ; Burgess, Tracy, MSc ; Fuster, Valentin, MD, PhD ; Rudd, James H.F., MD, PhD, MRCP (UK) ; Tawakol, Ahmed, MD ; Farkouh, Michael E., MD, MSc
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19Coronary Disease - drug therapy
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45Positron-Emission Tomography - methods
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47Retrospective Studies
48Risk Factors
49Statins
50Sulfhydryl Compounds - administration & dosage
51Sulfhydryl Compounds - therapeutic use
52Tomography
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54Treatment Outcome
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atitleRationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography
jtitleThe American heart journal
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abstractdal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is linked to increased risk of coronary heart disease (CHD). Dalcetrapib, a compound that increases high-density lipoprotein cholesterol by modulating cholesteryl ester transfer protein, is being studied to assess if it can reduce the progression of atherosclerotic disease and thereby decrease cardiovascular morbidity and mortality. Patients with CHD or CHD-risk equivalents were randomized to receive 600 mg dalcetrapib or placebo daily for 24 months, in addition to conventional lipid-lowering medication and other medications for cardiovascular risk factors. The primary outcomes are the effect of dalcetrapib on 18F-fluorodeoxyglucose positron emission tomography target-to-background ratio after 6 months and magnetic resonance imaging (MRI) plaque burden (wall area, wall thickness, total vessel area, and wall area/total vessel area ratio) after 12 months. Secondary objectives include positron emission tomography target-to-background ratio at 3 months and MRI plaque burden at 6 and 24 months; plaque composition at 6, 12, and 24 months; and aortic compliance at 6 months. A tertiary objective is to examine the dynamic contrast-enhanced MRI parameters of plaque neovascularization. In total, 189 subjects entered screening, and 130 were randomized. dal-PLAQUE will provide important information on the effects of dalcetrapib on markers of inflammation and atherosclerotic plaque burden and, thereby, on the safety of cholesteryl ester transfer protein modulation with dalcetrapib. Results are expected in 2011.
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