Ischemic Heart DiseaseAlgorithm-PCINCT04304677
Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes
An observational study of Ischemic Heart Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Therefore, the purpose of percutaneous coronary intervention (PCI) is to relieve myocardial ischemia caused by the target stenosis. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 486 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2016to 1 Oct 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement and pullback recording, then treated by DES with invasive physiologic evaluation at the index procedure.
Who may be able to join
- any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- any patient who underwent PCI for lesions with pre-PCI FFR<=0.80
- available pre-PCI FFR pullback recording
- available both post-PCI FFR measurement
Who cannot join
- unavailable pre-PCI FFR pullback recording
- unavailable post-PCI FFR measurement
- culprit vessel of acute coronary syndrome
- failed achieving TIMI 3 flow at the end of PCI
- left ventricular ejection fraction <30%
- graft vessel
Show all 11Show fewer
- collateral feeder
- in-stent restenosis
- primary myocardial or valvular heart disease
- in patient whose life expectancy less than 2 years
- visible thrombus of target vessel segment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes (Algorithm-PCI)
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Therefore, the purpose of percutaneous coronary intervention (PCI) is to relieve myocardial ischemia caused by the target stenosis. Fractional flow reserve (FFR) is an invasive physiologic index used to define functionally significant coronary stenosis, and its prognostic implications are supported by numerous studies. Contrary to the clear cutoff value and the benefit of FFR in pre-PCI evaluation, there have been various results regarding optimal cut-off values for post-PCI FFR. Nevertheless, the positive association between post-PCI FFR and the risk of future events has been reproduced by several studies.
PCI with stent implantation is basically a local treatment and post-PCI FFR reflects both residual stenosis in the stented segment and remaining disease beyond the stented segment in the target vessel(s).
Read more
Therefore, post-PCI FFR alone cannot fully discriminate the degree of contribution of each component. The relative increase of FFR with PCI is determined by the interaction of baseline severity of a target lesion, baseline disease burden of a target vessel, adequacy of PCI and residual disease burden in a target vessel.
However, the most important problem in stratifying patients with better expected post-PCI physiologic results and following clinical outcome would be that there has been no clear method to identify these patients in pre-PCI phase.
In this regard, we hypothesized that the amount of FFR step-up in pre-PCI pullback recording would determine the physiologic nature of target stenosis. For example, stenosis with sufficient step-up of FFR would deserve local treatment with PCI and these lesions would result in higher percent FFR increase, post-PCI FFR, and better clinical outcome than those without sufficient amount of FFR step-up.
For this, we sought to develop automated algorithm to define physiologic major stenosis versus minor stenosis using pre-PCI pullback recording.
Read the detailed description
The current study cohort consisted with 3 cohort. In order to derive and validate the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the below 3 cohorts will be used.
- Derivation cohort of defining the optimal cut off value of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise. The cohort of no coronary atherosclerosis confirmed by both angiography and intravascular ultrasound will be derived from patients with heart transplantation (NCT02798731). The cohort of significant focal or diffuse obstructive coronary artery disease with functional significance defined by FFR<=0.80 will be derived from post-PCI registry of Samsung Medical Center.
- Internal validation cohort will be post-PCI registry of Samsung Medical Center which enrolled 236 patients who underwent both pre- and post-PCI physiologic assessment after angiographically successful PCI using 2nd generation drug-eluting stent. Among this cohort, 234 patients with available pre-PCI pullback recording will be analyzed.
- External validation cohort will be COE-PERSPECTIVE registry (NCT01873560) which enrolled patients who underwent PCI for lesions with FFR<=0.80 and underwent post-PCI physiologic assessment.
Among the 835 patients, 252 patients with available pre-PCI pullback recording will be analyzed.
For the association between physiologic major, minor, or mixed stenosis classified using the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the patient level pooled data of both Samsung Medical Center registry and COE-PERSPECTIVE registry will be used.
- Conditions
- Ischemic Heart Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- fractional flow reserve, delta FFR per unit time, percutaneous coronary intervention, prognosis
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
Also called Fractional flow reserve
- Pre-PCI FFR pullback recording was done with conventional system
- Automated algorithm to calculate delta FFR per unit time was developed
- PCI was performed using 2nd generation DES
| Study group | Role | What they receive |
|---|---|---|
| Pre PCI state | The current study will analyze the pre-PCI pullback recording and amount of FFR step-up. The association of the amount of FFR step-up with post-PCI percent FFR increase, post-PCI FFR, and clinical outcome at 2 years will be analyzed Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent FFR increase after PCI
([Post-PCI FFR - Pre-PCI FFR]/Pre-PCI FFR * 100)
Measured: Immediate post-PCI
Post-PCI FFR
FFR value measured after angiographically successful PCI
Measured: Immediate post-PCI
Secondary outcomes (1)
Target Vessel Failure
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.
Measured: 2 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start22 Mar 2016
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 486 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Sejong General Hospital, Seoul National University Hospital
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304677
- Sponsor's protocol ID
- Algorithm20200211
- Acronym
- Algorithm-PCI
- Status last verified
- Oct 2022
- First submitted
- 9 Mar 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified patient data will be shared upon reasonable request after discussion in executive committee and developer of algorithm.
Publications
Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.
PubMed 34412795Lee SH, Shin D, Lee JM, Lefieux A, Molony D, Choi KH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Kwak JJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Nam CW, Koo BK, Choi SH, Gwon HC. Automated Algorithm Using Pre-Intervention Fractional Flow Reserve Pullback Curve to Predict Post-Intervention Physiological Results. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2670-2684. doi: 10.1016/j.jcin.2020.06.062. Epub 2020 Oct 14.
PubMed 33069650
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes (Algorithm-PCI)
- ClinicalTrials.gov ID
- NCT04304677
- Acronym / sponsor ID
- Algorithm-PCI / Algorithm20200211
- Conditions
- Ischemic Heart Disease
- Keywords
- fractional flow reserve, delta FFR per unit time, percutaneous coronary intervention, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Sejong General Hospital, Seoul National University Hospital
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Therefore, the purpose of percutaneous coronary intervention (PCI) is to relieve myocardial ischemia caused by the target stenosis. Fractional flow reserve (FFR) is an invasive physiologic index used to define functionally significant coronary stenosis, and its prognostic implications are supported by numerous studies. Contrary to the clear cutoff value and the benefit of FFR in pre-PCI evaluation, there have been various results regarding optimal cut-off values for post-PCI FFR. Nevertheless, the positive association between post-PCI FFR and the risk of future events has been reproduced by several studies.
PCI with stent implantation is basically a local treatment and post-PCI FFR reflects both residual stenosis in the stented segment and remaining disease beyond the stented segment in the target vessel(s).
Therefore, post-PCI FFR alone cannot fully discriminate the degree of contribution of each component. The relative increase of FFR with PCI is determined by the interaction of baseline severity of a target lesion, baseline disease burden of a target vessel, adequacy of PCI and residual disease burden in a target vessel.
However, the most important problem in stratifying patients with better expected post-PCI physiologic results and following clinical outcome would be that there has been no clear method to identify these patients in pre-PCI phase.
In this regard, we hypothesized that the amount of FFR step-up in pre-PCI pullback recording would determine the physiologic nature of target stenosis. For example, stenosis with sufficient step-up of FFR would deserve local treatment with PCI and these lesions would result in higher percent FFR increase, post-PCI FFR, and better clinical outcome than those without sufficient amount of FFR step-up.
For this, we sought to develop automated algorithm to define physiologic major stenosis versus minor stenosis using pre-PCI pullback recording.
Detailed description
The current study cohort consisted with 3 cohort. In order to derive and validate the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the below 3 cohorts will be used.
- Derivation cohort of defining the optimal cut off value of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise. The cohort of no coronary atherosclerosis confirmed by both angiography and intravascular ultrasound will be derived from patients with heart transplantation (NCT02798731). The cohort of significant focal or diffuse obstructive coronary artery disease with functional significance defined by FFR<=0.80 will be derived from post-PCI registry of Samsung Medical Center.
- Internal validation cohort will be post-PCI registry of Samsung Medical Center which enrolled 236 patients who underwent both pre- and post-PCI physiologic assessment after angiographically successful PCI using 2nd generation drug-eluting stent. Among this cohort, 234 patients with available pre-PCI pullback recording will be analyzed.
- External validation cohort will be COE-PERSPECTIVE registry (NCT01873560) which enrolled patients who underwent PCI for lesions with FFR<=0.80 and underwent post-PCI physiologic assessment.
Among the 835 patients, 252 patients with available pre-PCI pullback recording will be analyzed.
For the association between physiologic major, minor, or mixed stenosis classified using the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the patient level pooled data of both Samsung Medical Center registry and COE-PERSPECTIVE registry will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre PCI state | – | Device: Percutaneous coronary interventionThe current study will analyze the pre-PCI pullback recording and amount of FFR step-up. The association of the amount of FFR step-up with post-PCI percent FFR increase, post-PCI FFR, and clinical outcome at 2 years will be analyzed |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement and pullback recording, then treated by DES with invasive physiologic evaluation at the index procedure.
Key inclusion criteria (4 listed)
- any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- any patient who underwent PCI for lesions with pre-PCI FFR<=0.80
- available pre-PCI FFR pullback recording
- available both post-PCI FFR measurement
Key exclusion criteria (11 listed)
- unavailable pre-PCI FFR pullback recording
- unavailable post-PCI FFR measurement
- culprit vessel of acute coronary syndrome
- failed achieving TIMI 3 flow at the end of PCI
- left ventricular ejection fraction <30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionAlso: Fractional flow reserve1. Pre-PCI FFR pullback recording was done with conventional system 2. Automated algorithm to calculate delta FFR per unit time was developed 3. PCI was performed using 2nd generation DES | Device | Pre PCI state |
Primary outcome
Percent FFR increase after PCI
Time frame: Immediate post-PCI
([Post-PCI FFR - Pre-PCI FFR]/Pre-PCI FFR * 100)
Post-PCI FFR
Time frame: Immediate post-PCI
FFR value measured after angiographically successful PCI
1 secondary outcome
Target Vessel Failure
Time frame: 2 years after index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 34412795Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.
- Derived from this study: PubMed 33069650Lee SH, Shin D, Lee JM, Lefieux A, Molony D, Choi KH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Kwak JJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Nam CW, Koo BK, Choi SH, Gwon HC. Automated Algorithm Using Pre-Intervention Fractional Flow Reserve Pullback Curve to Predict Post-Intervention Physiological Results. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2670-2684. doi: 10.1016/j.jcin.2020.06.062. Epub 2020 Oct 14.
- Individual participant dataSharing planned: Undecided. De-identified patient data will be shared upon reasonable request after discussion in executive committee and developer of algorithm.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent FFR increase after PCI (time frame: Immediate post-PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022; AzTrials last refreshed its copy on 29 Oct 2026.