Endothelial Dysfunction and Plaque Vulnerability
| Tracking Information | |||||
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| First Received Date ICMJE | April 11, 2012 | ||||
| Last Updated Date | April 14, 2012 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01578616 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Endothelial Dysfunction and Plaque Vulnerability | ||||
| Official Title ICMJE | Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Yokohama City University Medical Center |
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| Condition ICMJE | Acute Coronary Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01578616 | ||||
| Other Study ID Numbers ICMJE | RHI OCT study | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kiyoshi Hibi, Yokohama City University Medical Center | ||||
| Study Sponsor ICMJE | Yokohama City University Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Yokohama City University Medical Center | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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