Clinical Trial: Impaired Peripheral Endothelial Function and In-stent Restenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Impaired Peripheral Endothelial Function as Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis

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).

Detailed Summary: 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.
Sponsor: Kumamoto University

Current Primary Outcome: Presence or absence of in-stent restenosis [ Time Frame: within 1 year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Endothelial Function [ Time Frame: within 1 year ]

Fingertip reactive hyperemia peripheral arterial tonometry (RH-PAT) is a new device that provides noninvasive, automatic, and quantitative evaluation of endothelial dysfunction with low intra- and inter-observer variability. We assess the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI). RHI will be measured using Endo-PAT2000 (Itamar Medical, Caesarea, Israel) before PCI (initial RHI) and at follow-up angiography (F/U RHI) in consecutive patients who had successful PCI in de novo coronary lesions.


Original Secondary Outcome: Same as current

Information By: Kumamoto University

Dates:
Date Received: May 1, 2014
Date Started: January 2010
Date Completion:
Last Updated: May 24, 2014
Last Verified: May 2014