BifurcationPOMPEINCT04501549
Plaque mOrphology iMpact on Side Branch Occlusion at oPtical Coherence Tomography Evaluation in Percutaneous Coronary Interventions
An observational study of Bifurcation and Percutaneous Coronary Intervention, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
Despite recent advances in interventional cardiology, bifurcation coronary artery stenoses (which account for 15-20% of all coronary lesions treated by PCI), remain a challenge for PCI operators with higher rates of failure, in-stent restenosis, stent thrombosis, and recurrent clinical events, when compared to simple… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Bifurcation, Percutaneous Coronary Intervention
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Jul 2018to 14 Apr 2021
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient waiting lists will be screened for patients undergoing election PCI for known bifurcation lesions. Patients will also be recruited after the elective PCI procedure. Patients who have undergone elective PCI for a bifurcation lesion which fits the criteria below, and had OCT performed during the procedure for clinical reasons.
Who may be able to join
- Age≥21 years of age
- Able to provide consent
- At least one de-novo bifurcation lesion involving a side-branch (SB) ≥ 2mm and SB ostial lesion ≥50% and <90% by visual assessment intended to be treated by PCI with provisional stenting strategy
- TIMI flow 3 in both MV and SB
Who cannot join
- Previous PCI of the target vessel
- Cardiac arrest or cardiogenic shock
- Left main or saphenous venous graft bifurcation
- Significant renal impairment patients (eGFR<30) who are not on dialysis
- Inability to advance the OCT catheter or to obtain good image quality
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Vanessa Wan, +6567042273, vanessa.wan@nhcs.com.sg
Chin Chee Yang, MD
About this study
Official title: Plaque mOrphology iMpact on Side Branch Occlusion at oPtical Coherence Tomography Evaluation in Percutaneous Coronary Interventions: The POMPEI Study
Despite recent advances in interventional cardiology, bifurcation coronary artery stenoses (which account for 15-20% of all coronary lesions treated by PCI), remain a challenge for PCI operators with higher rates of failure, in-stent restenosis, stent thrombosis, and recurrent clinical events, when compared to simple non-bifurcation lesions.
POMPEI trial is a prospective observational study. We aim to investigate the impact of morphological plaque characteristics assessed by optical coherence tomography (OCT) on the risk of developing side branch occlusion (SBO) in bifurcation PCI.
Read more
A total of 27 patients undergoing bifurcation PCI will be recruited into the trial. PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin. The OCT data analysis will be performed in collaboration with Dr Valeria Paradies who has been trained in interventional cardiology in Rotterdam (The Netherlands) with specific interest in intravascular imaging.
In conclusion, we will use OCT to detect specific morphological characteristics which are associated with acute SBO following main vessel stenting. The routine use of OCT during bifurcation PCI to detect those patients at risk of acute SBO following main vessel stenting will allow the PCI operator to implement measures for reducing the risk of SBO, thereby minimizing the risk of peri- and post-PCI angina, preventing peri-procedural myocardial injury and infarction, and improving clinical outcomes.
Read the detailed description
We hypothesized that in bifurcation lesion treatment, morphology of the plaque located in the main vessel may impact on the risk of developing SBO.
The objectives of POMPEI study as follows:
Primary objective:
To identify correlation between lipid volume content of MV plaque and risk of SBO (TIMI flow<3)
Secondary objectives:
To identify the plaque morphology characteristics associated with SBO in patients undergoing bifurcation PCI. OCT parameters which will be assessed include: distribution of lipid volume and lipid arc in the MV and around SB ostium before and after stenting; prevalence of healed plaque rupture and erosion and its correlation with SBO; correlation between calcium distribution within the plaque and SBO; correlation between bifurcation angle and SBO; and correlation between angiographic images of haziness at SB ostium and OCT findings.
To determine the prevalence of significant SB ostium stenosis in patients undergoing bifurcation PCI.
To determine the incidences of SBO following bifurcation PCI.
To determine the incidence and extent of peri-procedural myocardial injury and infarction following bifurcation PCI.
To determine correlation between SB lesion extension from the ostium and SBO
- Conditions
- Bifurcation, Percutaneous Coronary Intervention
- Being tested
- percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin.
What is being measured
The primary outcome is the main question the study is designed to answer.
To undertake a proof-of-concept clinical study to investigate the impact of morphological plaque characteristics on the risk of developing SBO in bifurcation lesion treatment
If we can show that different culprit plaques behave differently, then there is the potential to undertake a larger study to change the way we manage these plaques and therapies to prevent SBO.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start23 Jul 2018
- Primary completion14 Apr 2021 (estimated)
- Study completion14 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BifurcationStudies of the same condition, open and under way.
- 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin Chee Yang, MD, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501549
- Sponsor's protocol ID
- 2018/2493
- Acronym
- POMPEI
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque mOrphology iMpact on Side Branch Occlusion at oPtical Coherence Tomography Evaluation in Percutaneous Coronary Interventions: The POMPEI Study
- ClinicalTrials.gov ID
- NCT04501549
- Acronym / sponsor ID
- POMPEI / 2018/2493
- Conditions
- Bifurcation, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 14 Apr 2021 (estimated)
- Study completion
- 14 Apr 2021 (estimated)
- First posted
- 6 Aug 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.
Despite recent advances in interventional cardiology, bifurcation coronary artery stenoses (which account for 15-20% of all coronary lesions treated by PCI), remain a challenge for PCI operators with higher rates of failure, in-stent restenosis, stent thrombosis, and recurrent clinical events, when compared to simple non-bifurcation lesions.
POMPEI trial is a prospective observational study. We aim to investigate the impact of morphological plaque characteristics assessed by optical coherence tomography (OCT) on the risk of developing side branch occlusion (SBO) in bifurcation PCI.
A total of 27 patients undergoing bifurcation PCI will be recruited into the trial. PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin. The OCT data analysis will be performed in collaboration with Dr Valeria Paradies who has been trained in interventional cardiology in Rotterdam (The Netherlands) with specific interest in intravascular imaging.
In conclusion, we will use OCT to detect specific morphological characteristics which are associated with acute SBO following main vessel stenting. The routine use of OCT during bifurcation PCI to detect those patients at risk of acute SBO following main vessel stenting will allow the PCI operator to implement measures for reducing the risk of SBO, thereby minimizing the risk of peri- and post-PCI angina, preventing peri-procedural myocardial injury and infarction, and improving clinical outcomes.
Detailed description
We hypothesized that in bifurcation lesion treatment, morphology of the plaque located in the main vessel may impact on the risk of developing SBO.
The objectives of POMPEI study as follows:
Primary objective:
To identify correlation between lipid volume content of MV plaque and risk of SBO (TIMI flow<3)
Secondary objectives:
To identify the plaque morphology characteristics associated with SBO in patients undergoing bifurcation PCI. OCT parameters which will be assessed include: distribution of lipid volume and lipid arc in the MV and around SB ostium before and after stenting; prevalence of healed plaque rupture and erosion and its correlation with SBO; correlation between calcium distribution within the plaque and SBO; correlation between bifurcation angle and SBO; and correlation between angiographic images of haziness at SB ostium and OCT findings.
To determine the prevalence of significant SB ostium stenosis in patients undergoing bifurcation PCI.
To determine the incidences of SBO following bifurcation PCI.
To determine the incidence and extent of peri-procedural myocardial injury and infarction following bifurcation PCI.
To determine correlation between SB lesion extension from the ostium and SBO
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient waiting lists will be screened for patients undergoing election PCI for known bifurcation lesions. Patients will also be recruited after the elective PCI procedure. Patients who have undergone elective PCI for a bifurcation lesion which fits the criteria below, and had OCT performed during the procedure for clinical reasons.
Key inclusion criteria (4 listed)
- Age≥21 years of age
- Able to provide consent
- At least one de-novo bifurcation lesion involving a side-branch (SB) ≥ 2mm and SB ostial lesion ≥50% and <90% by visual assessment intended to be treated by PCI with provisional stenting strategy
- TIMI flow 3 in both MV and SB
Key exclusion criteria (5 listed)
- Previous PCI of the target vessel
- Cardiac arrest or cardiogenic shock
- Left main or saphenous venous graft bifurcation
- Significant renal impairment patients (eGFR<30) who are not on dialysis
- Inability to advance the OCT catheter or to obtain good image quality
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 interventionPCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin. | Procedure or surgery | – |
Primary outcome
To undertake a proof-of-concept clinical study to investigate the impact of morphological plaque characteristics on the risk of developing SBO in bifurcation lesion treatment
Time frame: 1year
If we can show that different culprit plaques behave differently, then there is the potential to undertake a larger study to change the way we manage these plaques and therapies to prevent SBO.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
Related trials for Bifurcation
RecruitingObservational study
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
Aortoiliac Occlusive Disease
Not yet recruiting
Modified Jailed Balloon Technique vs Jailed Wire Technique in Coronary Bifurcation Intervention
Coronary Artery Disease
Enrolling by invitationObservational study
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Progress Bifurcation Global Registry
Coronary Artery Disease, Coronary Bifurcation Lesions
RecruitingObservational study
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm
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.
Chin Chee Yang, MD principal investigator
National Heart Centre Singapore
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 Bifurcation and Percutaneous Coronary Intervention, run by National Heart Centre Singapore at 1 site in Singapore.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Aug 2020. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VANESSA WAN (+6567062273, vanessa.wan@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To undertake a proof-of-concept clinical study to investigate the impact of morphological plaque characteristics on the risk of developing SBO in bifurcation lesion treatment (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.