Endothelial Dysfunction and Plaque Vulnerability

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Yokohama City University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kiyoshi Hibi, Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT01578616
First received: April 11, 2012
Last updated: April 14, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


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

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
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578616

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         
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

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 April 15, 2014