Impaired Peripheral Endothelial Function and In-stent Restenosis

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02131935
• Lead Sponsor: Kumamoto University

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 Description

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-09
• Status Verified: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-03
• Study First Posted: 2014-05-06
• Last Update Submitted: 2014-05-24
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

• Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.

Exclusion Criteria

• Exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected RH-PAT results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing RH-PAT with uncertain reason.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of in-stent restenosis	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.

Secondary Outcome Measures

Name	Time	Method
Endothelial Function	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.

Trial Locations

Locations (1)

Kumamoto University; 🇯🇵 Kumamoto, Japan