We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endothelial Dysfunction and Plaque Vulnerability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578616
First Posted: April 17, 2012
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kiyoshi Hibi, Yokohama City University Medical Center
  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

Further study details as provided by Kiyoshi Hibi, Yokohama City University Medical Center:

Enrollment: 100
Study Start Date: July 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Yokohama City University Medical Center
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578616


Locations
Japan
Division of Cardiology, Yokohama City University Medical Center
Yokohama, Japan, 232-0024
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Principal Investigator: Kiyoshi Hibi, MD, PhD Division of Cardiology, Yokohama City University Medical Center
  More Information

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
First Submitted: April 11, 2012
First Posted: April 17, 2012
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Kiyoshi Hibi, Yokohama City University Medical Center:
Coronary artery disease
Endothelial function
Optical coherence tomography
Thin cap fibroatheroma

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases