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

Autor: Jian-Yong Xiao, Bo Sun, Jing Gao, Xiang Li, Yin Liu, Ji-Xiang Wang, Kathleen H. Reilly, Haibo Wang
Rok vydání: 2018
Předmět:
Male
lcsh:Diseases of the circulatory (Cardiovascular) system
Time Factors
medicine.medical_treatment
030204 cardiovascular system & hematology
Percutaneous coronary intervention
Coronary artery disease
Study Protocol
0302 clinical medicine
Risk Factors
Medicine
030212 general & internal medicine
Myocardial infarction
Prospective Studies
Coronary Artery Bypass
Prospective cohort study
Major adverse cardiac events
Virtual histology intravascular ultrasound
Aged
80 and over
Graft Occlusion
Vascular
Middle Aged
Plaque
Atherosclerotic
Cardiac surgery
medicine.anatomical_structure
surgical procedures
operative
Treatment Outcome
Research Design
Cardiology
Female
Cardiology and Cardiovascular Medicine
Artery
Adult
medicine.medical_specialty
China
Adolescent
Risk Assessment
03 medical and health sciences
Young Adult
Predictive Value of Tests
Internal medicine
Humans
Saphenous Vein
cardiovascular diseases
Ultrasonography
Interventional
Angiology
Aged
business.industry
medicine.disease
Saphenous vein graft disease
lcsh:RC666-701
Conventional PCI
business
Zdroj: BMC Cardiovascular Disorders
BMC Cardiovascular Disorders, Vol 18, Iss 1, Pp 1-7 (2018)
ISSN: 1471-2261
0317-5952
Popis: 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).
Databáze: OpenAIRE
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