Impaired Peripheral Endothelial Function and In-stent Restenosis

NCT ID: NCT02131935

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

513 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ISR Group

Patients Group Experienced In-Stent Restenosis (ISR)

No interventions assigned to this group

Non-ISR

Patients Group Without in-stent restenosis (ISR)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kumamoto University

OTHER

Sponsor Role lead

Responsible Party

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Kenichi Tsujita, MD, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hisao Ogawa, MD, PhD

Role: STUDY_CHAIR

Kumamoto University

Locations

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Kumamoto University

Kumamoto, Kumamoto, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 27317348 (View on PubMed)

Other Identifiers

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1120

Identifier Type: -

Identifier Source: org_study_id

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