Endothelial Dysfunction and Plaque Vulnerability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kiyoshi Hibi, Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT01578616
First received: April 11, 2012
Last updated: August 5, 2015
Last verified: August 2015

April 11, 2012
August 5, 2015
July 2010
May 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01578616 on ClinicalTrials.gov Archive Site
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Endothelial Dysfunction and Plaque Vulnerability
Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome
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).
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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample
Yokohama City University Medical Center
Acute Coronary Syndrome
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2014
May 2014   (final data collection date for primary outcome measure)

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:

Both
20 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01578616
RHI OCT study
No
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Kiyoshi Hibi, Yokohama City University Medical Center
Yokohama City University Medical Center
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Principal Investigator: Kiyoshi Hibi, MD, PhD Division of Cardiology, Yokohama City University Medical Center
Yokohama City University Medical Center
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP