Prognostic Implications of Physiologic Investigation After Revascularization With Stent

NCT ID: NCT04684043

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-16
• Study Completion Date: 2021-02-28

Brief Summary

Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI) and revascularization compared to medical therapy. However, the risk of future clinical events remains high, and about 10% of patients experienced further cardiovascular events after PCI. Several factors are associated with these poor outcomes. Well known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI, and presentation with the acute coronary syndrome. Procedure-related factors, such as stent underexpension, malapposition, edge dissection, the number of the used stent, and total stent length, are also related to poor prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after coronary stenting, or post PCI FFR, was associated with future clinical outcomes after PCI, and low post PCI FFR value was associated with procedural factors. However, optimal cut-off values of post-PCI FFR ranged widely, from 0.86 to 0.96, and some study reported the limited prognostic value of post-PCI FFR. This might result from differences in study populations, the definition of outcomes, type of stent used, and distribution of included vessels among previous studies.

To establish the clinical relevance of post-PCI FFR and to evaluate the useful cut-off value of post-PCI FFR in daily practice, investigators planned to incorporate all previous evidence of post-PCI FFR by collaboration with international researchers.

Detailed Description

This study population was incorporated from studies which were already published. Investigators will incorporate all known registries to the POST-PCI FLOW registry by requesting data from principal investigator of each registry.

Investigators will perform systemic review of the previous published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. Searching key words included 'post', 'after', 'PCI', 'Percutaneous coronary intervention', 'coronary stenting', 'stenting', 'stent', 'stent implantation', 'FFR', and 'fractional flow reserve'.

Conditions

Coronary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Post PCI state

The study population of this study underwent percutaneous coronary intervention(PCI) with drug-eluting stent (DES) and measured fractional flow reserve after PCI.

Percutaneous coronary intervention

Intervention Type: DEVICE

PCI was performed using drug-eluting stents

Interventions

Percutaneous coronary intervention

PCI was performed using drug-eluting stents

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with life expectancy < 2 years.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inje University Ilsan Paik Hospital, Goyang, South Korea

UNKNOWN

Sponsor Role: collaborator

Nanjing First Hospital, Nanjing Medical University, Nanjing, China

UNKNOWN

Sponsor Role: collaborator

Tsuchiura Kyodo General Hospital

OTHER

Sponsor Role: collaborator

McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA

UNKNOWN

Sponsor Role: collaborator

Nagoya City University Graduate School of Medical Science, Nagoya, Japan

UNKNOWN

Sponsor Role: collaborator

Rutgers Robert Wood Johnson Medical School

OTHER

Sponsor Role: collaborator

Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium

UNKNOWN

Sponsor Role: collaborator

San Raffaele Scientific Institute, Milan, Italy

UNKNOWN

Sponsor Role: collaborator

Ajou University Hospital, Suwon, South Korea

UNKNOWN

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Kyoto Second Red Cross Hospital, Kyoto, Japan

UNKNOWN

Sponsor Role: collaborator

Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

UNKNOWN

Sponsor Role: collaborator

Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

UNKNOWN

Sponsor Role: collaborator

Bon-Kwon Koo

OTHER

Sponsor Role: lead

Responsible Party

Bon-Kwon Koo

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bon-Kwon Koo, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital, Seoul, South Korea

Joon Hyung MD, PhD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University Ilsan Paik Hospital, Goyang, South Korea

Shao-Liang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing First Hospital, Nanjing Medical University, Nanjing, China

Tsunekazu Kakuta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tsuchiura Kyodo General Hospital

Nils P. Johnson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA

Tsuyoshi Ito, MD

Role: PRINCIPAL_INVESTIGATOR

Nagoya City University Graduate School of Medical Science, Nagoya, Japan

Abdul Hakeem, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Bernard De Bruyne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium

Lorenzo Azzalini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute, Milan, Italy

Hong-Seok Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University Hospital, Suwon, South Korea

Massoud A. Leesar, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Akiko Matsuo, MD

Role: PRINCIPAL_INVESTIGATOR

Kyoto Second Red Cross Hospital, Kyoto, Japan

Nobuhiro Tanaka, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

Joo Myung Lee, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Locations

Seoul National University Hospital

Seoul, Select, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Bon-Kwon Koo, MD, PhD

Role: CONTACT

bkkoo@snu.ac.kr

82-2-2072-2062

Doyeon Hwang, MD

Role: CONTACT

cardiol.intv@gmail.com

82-10-7446-2779

Facility Contacts

Bon-Kwon Koo, MD, PhD

Role: primary

bkkoo@snu.ac.kr

+82-1033561869

Seokhun Yang, MD

Role: backup

newturnz7@gmail.com

+82-1025953470

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Choi KH, Kwon W, Shin D, Lee SH, Hwang D, Zhang J, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Differential Impact of Fractional Flow Reserve Measured After Coronary Stent Implantation by Left Ventricular Dysfunction. JACC Asia. 2023 Dec 12;4(3):229-240. doi: 10.1016/j.jacasi.2023.10.009. eCollection 2024 Mar.

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Other Identifiers

H-2009-042-1155

Identifier Type: -

Identifier Source: org_study_id