Endothelial Dysfunction and Plaque Vulnerability
Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome
1 other identifier
observational
100
1 country
1
Brief Summary
Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. The high resolution of optical coherence tomography (OCT) provides an accurate measurement of fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic and quantitative method to evaluate endothelial function. The investigators will investigate the association between endothelial function assessed by RH-PAT and plaque vulnerability determined by OCT-derived thin-cap fibroatheroma (TCFA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedAugust 7, 2015
August 1, 2015
3.8 years
April 11, 2012
August 5, 2015
Conditions
Keywords
Study Arms (2)
3 / non-CAD, ACS with or without TCFA
ACS patients with thin cap fibroatheroma. ACS patients without thin cap fibroatheroma. Age-, gender-, and rate of hypertension or diabetes mellitus-matched patients who have never been diagnosed or treated for CAD are also enrolled as non-CAD patients
non-CAD, ACS without TCFA, ACS with TCFA
Acute coronary syndrome (ACS) patients with thin cap fibroatheroma. ACS patients without thin cap fibroatheroma. Age-, gender-, and rate of hypertension or diabetes mellitus-matched patients who have never been diagnosed or treated for CAD are also enrolled as non-CAD patients
Eligibility Criteria
Yokohama City University Medical Center
You may qualify if:
- patients with angiographically proven ACS (luminal stenosis of at least 50%) who undergo both OCT examination before coronary stent implantation and RH-PAT examination before discharge.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Yokohama City University Medical Center
Yokohama, 232-0024, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiyoshi Hibi, MD, PhD
Division of Cardiology, Yokohama City University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 17, 2012
Study Start
July 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
August 7, 2015
Record last verified: 2015-08