Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05672862
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2021-11-04
Brief Title:
International Post-PCI FFR Extended Registry
Sponsor:
Bon-Kwon Koo
Organization:
Seoul National University Hospital
Study Overview
Official Title:
International Post-PCI FFR Registry for Extended Follow up Outcomes After Coronary Stenting
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 acute coronary syndrome Procedure-related factors such as stent under expansion malposition 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 086 to 096 and some studies 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 Previously the investigators incorporated previous data into the International Post-PCI FFR registry and demonstrated the prognostic value of post-PCI FFR using the machine learning technique However the results were based on the two years follow-up of patients after PCI and the prognostic value of post-PCI FFR in long-term outcomes is still uncertain Therefore the investigators planned to extend the International Post-PCI FFR registry to define the long-term prognostic implication of post-PCI FFR
Detailed Description:
The investigators planned to extend the International Post-PCI FFR registry NCT04684043 to explore the long-term prognostic value of post-PCI FFR The International Post-PCI FFR registry NCT04684043 already included the 2200 patients who underwent PCI and measured post-PCI FFR between June 2011 and May 2018 As the clinical angiographic and physiologic data are already collected in the International Post PCI FFR registry the investigators will further collect the most recent clinical outcome data until 20215 and incorporate them into the International Post-PCI FFR Extended registry As the current study will evaluate clinical outcomes at 5 years 2128 patients who underwent PCI and measured post-PCI FFR between June 2011 and Nov 2016 will be included and studied The investigators will request further clinical outcome data from 10 hospitals that provided the data for the International Post-PCI FFR registry before
A standardized form of a spreadsheet including standardized definitions of variables was used to collect the individual patient data from the principal investigators of each qualified registry Patient clinical angiographic and physiologic data at the time of index PCI were recorded and already collected at Seoul National University Hospital As clinical outcome data of 2 years of follow-up after index PCI are already collected in the International Post-PCI FFR registry NCT04684043 clinical outcome data after 2 years of index PCI will be collected by medical records until 20215 of each hospital All submitted data were double-checked by a central monitoring team in Seoul National University Hospital All patients identifying numbers are anonymized as Subject_No and the investigators will request the patients clinical outcome data using these anonymized identifying numbers of the patients Also the investigators will share collected data with collaborators using these numbers
A standardized form of a spreadsheet including standardized definitions of variables was used to collect the individual patient data from the principal investigators of each qualified registry Patient clinical angiographic and physiologic data at the time of index PCI were recorded and already collected at Seoul National University Hospital As clinical outcome data of 2 years of follow-up after index PCI are already collected in the International Post-PCI FFR registry NCT04684043 clinical outcome data after 2 years of index PCI will be collected by medical records until 20215 of each hospital All submitted data were double-checked by a central monitoring team in Seoul National University Hospital All patients identifying numbers are anonymized as Subject_No and the investigators will request the patients clinical outcome data using these anonymized identifying numbers of the patients Also the investigators will share collected data with collaborators using these numbers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None