Relationship between plaque composition by virtual histology intravascular ultrasound and clinical outcomes after percutaneous coronary intervention in saphenous vein graft disease patients: study protocol of a prospective cohort study
Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been f...
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Published in | BMC cardiovascular disorders Vol. 18; no. 1; p. 233 |
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12.12.2018
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Abstract | Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI.
This is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. The planned sample size is 175 subjects. We will recruit subjects with SVGD scheduled to receive PCI, aged 18-80 years, with a history of previous coronary artery bypass graft (CABG) surgery more than 1 year ago, and willing to participate in the study and sign informed consent. The composite primary study endpoint is the incidence of MACEs after PCI for SVGD, including death from cardiac causes, non-fatal myocardial infarction, unplanned target lesion revascularization (TLR) and target vessel revascularization (TVR). The primary outcome analysis will be presented as Kaplan-Meier estimates and the primary outcome analysis will be carried out using a Cox proportional hazards regression model.
Once the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance.
The study is registered to ClinicalTrials.gov (NCT03175952). |
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AbstractList | Abstract Background Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI. Methods/design This is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. The planned sample size is 175 subjects. We will recruit subjects with SVGD scheduled to receive PCI, aged 18–80 years, with a history of previous coronary artery bypass graft (CABG) surgery more than 1 year ago, and willing to participate in the study and sign informed consent. The composite primary study endpoint is the incidence of MACEs after PCI for SVGD, including death from cardiac causes, non-fatal myocardial infarction, unplanned target lesion revascularization (TLR) and target vessel revascularization (TVR). The primary outcome analysis will be presented as Kaplan-Meier estimates and the primary outcome analysis will be carried out using a Cox proportional hazards regression model. Discussion Once the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance. Trial registration The study is registered to ClinicalTrials.gov (NCT03175952). Background Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI. Methods/design This is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. The planned sample size is 175 subjects. We will recruit subjects with SVGD scheduled to receive PCI, aged 18–80 years, with a history of previous coronary artery bypass graft (CABG) surgery more than 1 year ago, and willing to participate in the study and sign informed consent. The composite primary study endpoint is the incidence of MACEs after PCI for SVGD, including death from cardiac causes, non-fatal myocardial infarction, unplanned target lesion revascularization (TLR) and target vessel revascularization (TVR). The primary outcome analysis will be presented as Kaplan-Meier estimates and the primary outcome analysis will be carried out using a Cox proportional hazards regression model. Discussion Once the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance. Trial registration The study is registered to ClinicalTrials.gov (NCT03175952). Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI. This is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. Once the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance. BACKGROUNDPlaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI. METHODS/DESIGNThis is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. The planned sample size is 175 subjects. We will recruit subjects with SVGD scheduled to receive PCI, aged 18-80 years, with a history of previous coronary artery bypass graft (CABG) surgery more than 1 year ago, and willing to participate in the study and sign informed consent. The composite primary study endpoint is the incidence of MACEs after PCI for SVGD, including death from cardiac causes, non-fatal myocardial infarction, unplanned target lesion revascularization (TLR) and target vessel revascularization (TVR). The primary outcome analysis will be presented as Kaplan-Meier estimates and the primary outcome analysis will be carried out using a Cox proportional hazards regression model. DISCUSSIONOnce the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance. TRIAL REGISTRATIONThe study is registered to ClinicalTrials.gov (NCT03175952). Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI. This is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. The planned sample size is 175 subjects. We will recruit subjects with SVGD scheduled to receive PCI, aged 18-80 years, with a history of previous coronary artery bypass graft (CABG) surgery more than 1 year ago, and willing to participate in the study and sign informed consent. The composite primary study endpoint is the incidence of MACEs after PCI for SVGD, including death from cardiac causes, non-fatal myocardial infarction, unplanned target lesion revascularization (TLR) and target vessel revascularization (TVR). The primary outcome analysis will be presented as Kaplan-Meier estimates and the primary outcome analysis will be carried out using a Cox proportional hazards regression model. Once the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance. The study is registered to ClinicalTrials.gov (NCT03175952). Background Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk of clinical events following percutaneous coronary intervention (PCI) among coronary artery disease (CAD) patients. However, there have been few studies to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with saphenous vein graft disease (SVGD) undergoing PCI. The purpose of this study is to determine whether plaque components and characteristics by VH-IVUS can predict major adverse cardiac events (MACEs) among SVGD patients undergoing PCI. Methods/design This is a prospective cohort study conducted in Tianjin Chest Hospital, China. Participants with SVGD referred for PCI will be invited to participate in this study, and will be followed up at 1, 6, 12, 24 and 36 months post-PCI to assess clinical outcomes. The planned sample size is 175 subjects. We will recruit subjects with SVGD scheduled to receive PCI, aged 18-80 years, with a history of previous coronary artery bypass graft (CABG) surgery more than 1 year ago, and willing to participate in the study and sign informed consent. The composite primary study endpoint is the incidence of MACEs after PCI for SVGD, including death from cardiac causes, non-fatal myocardial infarction, unplanned target lesion revascularization (TLR) and target vessel revascularization (TVR). The primary outcome analysis will be presented as Kaplan-Meier estimates and the primary outcome analysis will be carried out using a Cox proportional hazards regression model. Discussion Once the predictive values of plaque components and characteristics by VH-IVUS on subsequent clinical outcomes are determined among SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes for SVGD patients undergoing PCI will be created, which may lead to the development of new methods of risk stratification and intervention guidance. Trial registration The study is registered to ClinicalTrials.gov (NCT03175952). Keywords: Saphenous vein graft disease, Virtual histology intravascular ultrasound, Percutaneous coronary intervention, Major adverse cardiac events |
ArticleNumber | 233 |
Audience | Academic |
Author | Wang, Ji-Xiang Sun, Bo Reilly, Kathleen H Liu, Yin Li, Xiang Gao, Jing Xiao, Jian-Yong Wang, Hai-Bo |
Author_xml | – sequence: 1 givenname: Yin surname: Liu fullname: Liu, Yin organization: Department of Cardiology, Tianjin Chest Hospital, No.261 Tai er zhuang Road, Jinnan District, Tianjin, 300222, People's Republic of China – sequence: 2 givenname: Hai-Bo surname: Wang fullname: Wang, Hai-Bo organization: Peking University Clinical Research Institute, Xueyuan Rd 38#, Haidian Dist, Beijing, 100191, People's Republic of China – sequence: 3 givenname: Xiang surname: Li fullname: Li, Xiang organization: Peking University Clinical Research Institute, Xueyuan Rd 38#, Haidian Dist, Beijing, 100191, People's Republic of China – sequence: 4 givenname: Jian-Yong surname: Xiao fullname: Xiao, Jian-Yong organization: Department of Cardiology, Tianjin Chest Hospital, No.261 Tai er zhuang Road, Jinnan District, Tianjin, 300222, People's Republic of China – sequence: 5 givenname: Ji-Xiang surname: Wang fullname: Wang, Ji-Xiang organization: Department of Cardiology, Tianjin Chest Hospital, No.261 Tai er zhuang Road, Jinnan District, Tianjin, 300222, People's Republic of China – sequence: 6 givenname: Kathleen H surname: Reilly fullname: Reilly, Kathleen H organization: Independent Consultant, New York City, NY, USA – sequence: 7 givenname: Bo surname: Sun fullname: Sun, Bo organization: Department of Cardiology, Tianjin Chest Hospital, No.261 Tai er zhuang Road, Jinnan District, Tianjin, 300222, People's Republic of China – sequence: 8 givenname: Jing orcidid: 0000-0003-3191-1678 surname: Gao fullname: Gao, Jing email: heart201707@163.com organization: Cardiovascular Institute, Tianjin Chest Hospital, No.261 Tai er zhuang Road, Jinnan District, Tianjin, 300222, People's Republic of China. heart201707@163.com |
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Keywords | Saphenous vein graft disease Major adverse cardiac events Percutaneous coronary intervention Virtual histology intravascular ultrasound |
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Snippet | Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at increased risk... Background Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at... BACKGROUNDPlaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques at... Abstract Background Plaque composition and morphologic characteristics identified by virtual histology intravascular ultrasound (VH-IVUS) can determine plaques... |
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SubjectTerms | Adolescent Adult Aged Aged, 80 and over Analysis Angioplasty Atherosclerosis Cardiovascular disease China Clinical outcomes Cohort analysis Coronary artery Coronary artery bypass Coronary Artery Bypass - adverse effects Coronary Artery Bypass - mortality Coronary heart disease Coronary vessels Female Graft Occlusion, Vascular - diagnostic imaging Graft Occlusion, Vascular - mortality Graft Occlusion, Vascular - pathology Graft Occlusion, Vascular - surgery Heart Heart diseases Heart surgery Histology Hospitals Humans Intervention Major adverse cardiac events Male Medical imaging Middle Aged Mortality Myocardial infarction Percutaneous coronary intervention Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - mortality Physical characteristics Plaque, Atherosclerotic Plaques Predictive Value of Tests Prospective Studies Research Design Risk Assessment Risk Factors Saphenous Vein - diagnostic imaging Saphenous Vein - pathology Saphenous Vein - transplantation Saphenous vein graft disease Stents Studies Study Protocol Time Factors Treatment Outcome Ultrasonic imaging Ultrasonography, Interventional Ultrasound Virtual histology intravascular ultrasound Young Adult |
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Title | Relationship between plaque composition by virtual histology intravascular ultrasound and clinical outcomes after percutaneous coronary intervention in saphenous vein graft disease patients: study protocol of a prospective cohort study |
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