Endothelial Dysfunction and Plaque Vulnerability
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Purpose
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).
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Detailed Description:
Consecutive patients with acute coronary syndrome (ACS) who undergo both OCT examination and RH-PAT examination are enrolled. OCT examination is performed to observe the culprit lesion before percutaneous coronary intervention, and endothelial function is evaluated using RH-PAT before discharge.
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Yokohama City University Medical Center
Inclusion Criteria:
- 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.
Exclusion Criteria:
- none
Contacts and Locations| Japan | |
| Division of Cardiology, Yokohama City University Medical Center | Recruiting |
| Yokohama, Japan, 232-0024 | |
| Contact: Yasushi Matsuzawa, MD 81-45-261-5656 junejune@kumamoto-u.a.cjp | |
| Contact: Kiyoshi Hibi, MD, PhD 81-45-261-5656 hibikiyo@yokohama-cu.ac.jp | |
| Sub-Investigator: Kazuo Kimura, MD, PhD | |
| Sub-Investigator: Kenichiro Saka, MD | |
| Principal Investigator: | Kiyoshi Hibi, MD, PhD | Division of Cardiology, Yokohama City University Medical Center |
More Information
No publications provided
| Responsible Party: | Kiyoshi Hibi, Associate Professor of Medicine, Yokohama City University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01578616 History of Changes |
| Other Study ID Numbers: | RHI OCT study |
| Study First Received: | April 11, 2012 |
| Last Updated: | April 14, 2012 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Yokohama City University Medical Center:
|
Coronary artery disease Endothelial function Optical coherence tomography Thin cap fibroatheroma |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013