Prognostic Implications of Physiologic Investigation After Revascularization With Stent (POST-PCI FLOW)

February 23, 2021 updated by: Bon-Kwon Koo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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'.

Study Type

Observational

Enrollment (Anticipated)

5100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Select
      • Seoul, Select, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed as obstructive coronary artery disease and treated by DES and measured post PCI FFR after PCI.

Description

Articles were included when they met the following prespecified criteria: (1) included the patients who underwent PCI with drug-eluting stent (DES); (2) post-PCI FFR was measured after DES implantation; (3) pre-PCI FFR measurement was not mandatory for article inclusion; (4) patients were followed up at least 6 months; (5) clinical outcomes, including all-cause death, cardiac death, target vessel myocardial infarction (TVMI) or target vessel revascularization (TVR), were clearly reported; (6) randomized controlled trials or non-randomized prospective or retrospective registries were included. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the studies' inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.

  • Patients with life expectancy < 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Percutaneous coronary intervention
PCI was performed using drug-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel failure
Time Frame: 2 years
A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel revascularization
Time Frame: 2 years
2 years
Cardiac death or myocardial infarction
Time Frame: 2 years
a composite of cardiac death and target vessel myocardial infarction
2 years
Target vessel myocardial infarction
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cut-off value of post-PCI FFR
Time Frame: 2 years
Define the best cut-off value for predicting the future adverse events
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bon-Kwon Koo

Collaborators

University of Cincinnati
Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
Tsuchiura Kyodo General Hospital
Rutgers Robert Wood Johnson Medical School
Inje University Ilsan Paik Hospital, Goyang, South Korea
Nanjing First Hospital, Nanjing Medical University, Nanjing, China
Kyoto Second Red Cross Hospital, Kyoto, Japan
McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA
Nagoya City University Graduate School of Medical Science, Nagoya, Japan
San Raffaele Scientific Institute, Milan, Italy
Ajou University Hospital, Suwon, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

Investigators

  • Study Chair: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital, Seoul, South Korea
  • Principal Investigator: Joon Hyung MD, PhD, MD, PhD, Inje University Ilsan Paik Hospital, Goyang, South Korea
  • Principal Investigator: Nils P. Johnson, MD, MS, McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA
  • Principal Investigator: Tsuyoshi Ito, MD, Nagoya City University Graduate School of Medical Science, Nagoya, Japan
  • Principal Investigator: Abdul Hakeem, MD, Rutgers Robert Wood Johnson Medical School
  • Principal Investigator: Bernard De Bruyne, MD, PhD, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
  • Principal Investigator: Lorenzo Azzalini, MD, PhD, San Raffaele Scientific Institute, Milan, Italy
  • Principal Investigator: Hong-Seok Lim, MD, PhD, Ajou University Hospital, Suwon, South Korea
  • Principal Investigator: Massoud A. Leesar, MD, PhD, MSc, University of Cincinnati
  • Principal Investigator: Nobuhiro Tanaka, MD, PhD, MSc, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
  • Principal Investigator: Joo Myung Lee, MD, PhD, MSc, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2020

Primary Completion (ANTICIPATED)

February 28, 2021

Study Completion (ANTICIPATED)

February 28, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2009-042-1155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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