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International Post PCI FFR Registry
| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Disease | Device: Percutaneous coronary intervention |
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 still remain high and about 10% of patients experienced further cardiovascular events after PCI. There are several factors that are associated with these poor outcomes. 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, all of these risk factors were identified in individual studies there have been no studies that comprehensively evaluated these risk factors. Therefore, the investigators sought to investigate the risk predictors of future clinical events in patients after PCI and develop a risk model, incorporating clinical, angiographic, and physiologic factors, to predict the clinical events after PCI using contemporary coronary stents.
The study population of this study is from the International Post PCI FFR Registry, which included 4 different registries from Korea, China, and Japan. All patients in this registry are available with clinical, angiographic and physiologic data and used 2nd generation drug-eluting stent (DES) for PCI. The COE-PERSPECTIVE registry (NCT01873560) was designed to evaluate the clinical relevance of post PCI FFR from 9 hospitals in Korea and Japan and enrolled a total of 835 patients available post PCI FFR value after angiographically successful PCI between May 2013 and December 2016. The 3V-FFR-FRIENDS registry (NCT01621438) enrolled a total of 1,136 patients (3,298 vessels) who underwent 3-vessel FFR measurements from 12 centers in Korea, Japan, and China between November 2011 and March 2014. Among them, 266 patients with 337 vessels who measure post PCI FFR values were included in this international registry. The DKCRUSH VII registry (ChiCTR-PRCH-12001976) enrolled a total of 1,476 patients from 9 hospitals (5 hospitals in China, 2 hospitals in the United States, 1 hospital in Asia and 1 hospital in European country) between May 2012 and September 2013 to evaluate the prognostic value of post PCI FFR on patients' future outcome. For this international registry, 780 patients with 794 vessels from Nanjing First Hospital in China, who were available with whole clinical, angiographic and physiologic data, were included in this registry. Last, the Institutional registry of Tsuchiura Kyodo General Hospital, Ibaraki, Japan included 347 patients (357 vessels) who underwent PCI and final post-PCI FFR measurement.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 2228 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | International Post PCI FFR Registry for Prognostic Factors After Coronary Stenting |
| Actual Study Start Date : | August 17, 2010 |
| Actual Primary Completion Date : | February 11, 2019 |
| Actual Study Completion Date : | March 28, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Post PCI state
The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured fractional flow reserve after PCI
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Device: Percutaneous coronary intervention
PCI was performed using 2nd generation DES
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- Discrimination index of prediction model for target-vessel failure [ Time Frame: 2 years after index procedure ]
A risk model for target-vessel failure, incorporating clinical, angiographic, and additional physiologic predictors, will be developed using this cohort.
Target vessel failure is a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.
- Independent predictors for target vessel failure [ Time Frame: 2 years after index procedure ]Clinical, angiographic and physiologic covariables will be evaluated using machine learning for identifying the independent predictors (ex. random survival forest model).
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients who underwent PCI and post-PCI FFR measurements after angiographically successful stent implantation (residual stenosis < 20% by visual estimation)
- Patients who provided informed consent
Exclusion Criteria:
- Post-PCI TIMI flow of < 3
- Depressed left ventricular systolic function (ejection fraction < 30%)
- Culprit lesion for acute coronary syndrome
- Graft vessel
- Collateral feeder
- In-stent stenosis
- Primary myocardial or valvular heart disease
- Patients with life expectancy < 2 years.
| Study Director: | Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | |
| Principal Investigator: | Joon Hyung Doh, MD, PhD | Inje University | |
| Principal Investigator: | Shao-Liang Chen, MD | Nanjing First Hospital, Nanjing Medical University | |
| Principal Investigator: | Tsunekazu Kakuta, MD, PhD | Tsuchiura Kyodo General Hospital | |
| Principal Investigator: | Joo Myung Lee, MD, PhD | Samsung Medical Center |
| Tracking Information | ||||||||||||||||
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| First Submitted Date | July 3, 2019 | |||||||||||||||
| First Posted Date | July 9, 2019 | |||||||||||||||
| Last Update Posted Date | July 16, 2019 | |||||||||||||||
| Actual Study Start Date | August 17, 2010 | |||||||||||||||
| Actual Primary Completion Date | February 11, 2019 (Final data collection date for primary outcome measure) | |||||||||||||||
| Current Primary Outcome Measures |
Discrimination index of prediction model for target-vessel failure [ Time Frame: 2 years after index procedure ] A risk model for target-vessel failure, incorporating clinical, angiographic, and additional physiologic predictors, will be developed using this cohort.
Target vessel failure is a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.
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| Original Primary Outcome Measures | Same as current | |||||||||||||||
| Change History | ||||||||||||||||
| Current Secondary Outcome Measures |
Independent predictors for target vessel failure [ Time Frame: 2 years after index procedure ] Clinical, angiographic and physiologic covariables will be evaluated using machine learning for identifying the independent predictors (ex. random survival forest model).
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| Original Secondary Outcome Measures | Same as current | |||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
| Descriptive Information | ||||||||||||||||
| Brief Title | International Post PCI FFR Registry | |||||||||||||||
| Official Title | International Post PCI FFR Registry for Prognostic Factors After Coronary Stenting | |||||||||||||||
| Brief Summary | The prognostic factors after a percutaneous coronary intervention (PCI) have not been comprehensively investigated. The investigators sought to develop a risk model to predict future clinical events after PCI using contemporary coronary stents. | |||||||||||||||
| Detailed Description |
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 still remain high and about 10% of patients experienced further cardiovascular events after PCI. There are several factors that are associated with these poor outcomes. 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, all of these risk factors were identified in individual studies there have been no studies that comprehensively evaluated these risk factors. Therefore, the investigators sought to investigate the risk predictors of future clinical events in patients after PCI and develop a risk model, incorporating clinical, angiographic, and physiologic factors, to predict the clinical events after PCI using contemporary coronary stents. The study population of this study is from the International Post PCI FFR Registry, which included 4 different registries from Korea, China, and Japan. All patients in this registry are available with clinical, angiographic and physiologic data and used 2nd generation drug-eluting stent (DES) for PCI. The COE-PERSPECTIVE registry (NCT01873560) was designed to evaluate the clinical relevance of post PCI FFR from 9 hospitals in Korea and Japan and enrolled a total of 835 patients available post PCI FFR value after angiographically successful PCI between May 2013 and December 2016. The 3V-FFR-FRIENDS registry (NCT01621438) enrolled a total of 1,136 patients (3,298 vessels) who underwent 3-vessel FFR measurements from 12 centers in Korea, Japan, and China between November 2011 and March 2014. Among them, 266 patients with 337 vessels who measure post PCI FFR values were included in this international registry. The DKCRUSH VII registry (ChiCTR-PRCH-12001976) enrolled a total of 1,476 patients from 9 hospitals (5 hospitals in China, 2 hospitals in the United States, 1 hospital in Asia and 1 hospital in European country) between May 2012 and September 2013 to evaluate the prognostic value of post PCI FFR on patients' future outcome. For this international registry, 780 patients with 794 vessels from Nanjing First Hospital in China, who were available with whole clinical, angiographic and physiologic data, were included in this registry. Last, the Institutional registry of Tsuchiura Kyodo General Hospital, Ibaraki, Japan included 347 patients (357 vessels) who underwent PCI and final post-PCI FFR measurement. |
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| Study Type | Observational [Patient Registry] | |||||||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Years | |||||||||||||||
| Biospecimen | Not Provided | |||||||||||||||
| Sampling Method | Non-Probability Sample | |||||||||||||||
| Study Population | Patients who were diagnosed as obstructive coronary artery disease and treated by 2nd generation DES and measured post PCI FFR after PCI. | |||||||||||||||
| Condition | Coronary Disease | |||||||||||||||
| Intervention | Device: Percutaneous coronary intervention
PCI was performed using 2nd generation DES
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| Study Groups/Cohorts | Post PCI state
The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured fractional flow reserve after PCI
Intervention: Device: Percutaneous coronary intervention
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||||||||
| Recruitment Status | Completed | |||||||||||||||
| Actual Enrollment |
2228 | |||||||||||||||
| Original Actual Enrollment | Same as current | |||||||||||||||
| Actual Study Completion Date | March 28, 2019 | |||||||||||||||
| Actual Primary Completion Date | February 11, 2019 (Final data collection date for primary outcome measure) | |||||||||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 100 Years (Adult, Older Adult) | |||||||||||||||
| Accepts Healthy Volunteers | No | |||||||||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
| Listed Location Countries | Not Provided | |||||||||||||||
| Removed Location Countries | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number | NCT04012281 | |||||||||||||||
| Other Study ID Numbers | 1906-152-1044 | |||||||||||||||
| Has Data Monitoring Committee | Yes | |||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | |||||||||||||||
| Responsible Party | Bon-Kwon Koo, Seoul National University Hospital | |||||||||||||||
| Study Sponsor | Seoul National University Hospital | |||||||||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Seoul National University Hospital | |||||||||||||||
| Verification Date | July 2019 | |||||||||||||||
