Impaired Peripheral Endothelial Function and In-stent Restenosis
1 other identifier
observational
513
1 country
1
Brief Summary
The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedMay 28, 2014
May 1, 2014
3.7 years
May 1, 2014
May 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Presence or absence of in-stent restenosis
Based on the Japanese clinical routine, follow-up (F/U) angiography will be performed at six and nine months after PCI with bare-metal stent (BMS) and drug-eluting stent (DES), respectively. ISR was defined as percent diameter stenosis \>50% at F/U angiography assessed by quantitative coronary angiography.
within 1 year
Secondary Outcomes (1)
Endothelial Function
within 1 year
Study Arms (2)
ISR Group
Patients Group Experienced In-Stent Restenosis (ISR)
Non-ISR
Patients Group Without in-stent restenosis (ISR)
Eligibility Criteria
consecutive patient sampling This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kumamoto University
Kumamoto, Kumamoto, 860-8556, Japan
Related Publications (1)
Komura N, Tsujita K, Yamanaga K, Sakamoto K, Kaikita K, Hokimoto S, Iwashita S, Miyazaki T, Akasaka T, Arima Y, Yamamoto E, Izumiya Y, Yamamuro M, Kojima S, Tayama S, Sugiyama S, Matsui K, Nakamura S, Hibi K, Kimura K, Umemura S, Ogawa H. Impaired Peripheral Endothelial Function Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis. J Am Heart Assoc. 2016 Jun 17;5(6):e003202. doi: 10.1161/JAHA.116.003202.
PMID: 27317348DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hisao Ogawa, MD, PhD
Kumamoto University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 6, 2014
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
May 1, 2014
Last Updated
May 28, 2014
Record last verified: 2014-05