Chronic Coronary SyndromeINTERFORCENCT06275399
Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery
An observational study of Chronic Coronary Syndrome and Atherosclerosis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Atherosclerosis
- What is being tested?
- OCT examination, Blood sampling and Assessment of vFFR and shear stress parameters
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 21 Jul 2023to 21 Jul 2026
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis (30% - 90%) amenable to OCT imaging (according to the operator's judgment).
Who may be able to join
- Chronic coronary syndrome
- Angiographically confirmed coronary stenosis (30% - 90%)
- Amenable to OCT imaging
Who cannot join
- Cardiogenic shock
- ST-segment elevation or non-ST-segment elevation myocardial infarction
- Active bleeding
- Left main coronary artery disease
- Multivessel disease
- Lesions located at a distance ≤3 mm from the ostium of the vessel
Show all 10Show fewer
- Thrombocytopenia
- Previous coronary artery bypass grafting
- Previous coronary intervention with stent implantation or balloon angioplasty
- Previous use of novel oral anticoagulants or vitamin K antagonists
Trial locations and contacts
1 site in 1 country.
Adrian Bednarek contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Mariusz Tomaniak, MD, PhD, Assoc. Prof., mariusz.tomaniak@wum.edu.pl
Adrian Bednarek, adikbednarek@gmail.com
About this study
Official title: Comprehensive Assessment of Morphometric, Functional, Biomechanical, and Biological Interactions Between Atherosclerotic Plaque and Blood Platelets Within the Stenosed Coronary Artery in Vivo: a Prospective Study
The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery.
Read the detailed description
The biomechanical forces, including shear rate and shear stress exerted by circulating blood on the coronary wall and on circulating blood elements have been reported to contribute to the processes of plaque destabilization and thrombosis. Reliable estimation of shear (shear rate and shear stress) acting in vivo within the coronary artery has now become possible using imaging data and computational fluid dynamics techniques. The changing microenvironment of the plaque has a crucial role in the biochemical processes involved in remodeling the plaque itself. In this prospective, single-center study a total of 105 patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis (30% - 90%) amenable to OCT imaging (according to the operator's judgment).
The groups will be assessed at the time of angiography with:
- OCT examination for precise evaluation of plaque morphology within the coronary stenosis
- Computational fluid dynamics with vFFR and estimation of value and distribution of shear rate and shear stress
- Impedance aggregometry-based platelet reactivity
- Single-particle high-resolution flow cytometry analysis of platelet-derived microvesicles and small extracellular vesicles (sEVs) as well as additional platelet activation (P-selectin, annexin-V) and inflammatory biomarkers
- Proteomic and metabolomic characterization - in the subset of patients Biomarker assessment will be done in the blood sampled directly from coronary artery (proximal and distal segment).
- Conditions
- Chronic Coronary Syndrome, Atherosclerosis
- Being tested
- OCT examination, Blood sampling, Assessment of vFFR and shear stress parameters
- Keywords
- Optical Coherence Tomography, vFFR, Shear Rate, Impedance aggregometry, Shear stress, Proteomic, Metabolomic, Computational fluid dynamics, Prothrombotic platelet, Vulnerable plaque
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT examinationDiagnostic test
OCT examination for precise evaluation of plaque morphology within the coronary stenosis.
Blood samplingDiagnostic test
Blood sampling directly from coronary artery (proximal and distal segment) arteries
Assessment of vFFR and shear stress parametersDiagnostic test
The procedure is based on non-invasive assessment of vFFR and shear stress parameters with dedicated software, deriving parameters directly from coronary angiography with the calculation based on the computational fluid dynamics
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging | Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging. The groups will be assessed at the time of angiography with:
* OCT for evaluation of plaque morphology within the coronary stenosis
* Computational fluid dynamics with vFFR and estimation of value and distribution of shear rate and shear stress
* Impedance aggregometry based platelet reactivity
* Single-particle high-resolution flow cytometry analysis of pMVs and sEVs as well as additional platelet activation and inflammatory biomarkers
* Proteomic and metabolomic characterization - in the subset of patients
Biomarker assessment will be done in the blood sampled directly from coronary artery (proximal and distal segment) arteries. Shear rate/shear stress distribution and biomarkers profile will be compared between the stenotic vessel and the non-stenotic vessel (stenoses <30%) in the same patient. Receives: Diagnostic Test: OCT examination; Diagnostic Test: Blood sampling; Diagnostic Test: Assessment of vFFR and shear stress parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery.
Measured: Baseline
Secondary outcomes (14)
Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery
Inflammatory biomarkers will include sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-α, PlGF, IL-6, IL-18, IL-10, CCL2
Measured: Baseline
Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery
Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests
Measured: Baseline
Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs
Measured: Baseline
Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers
Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-α, PlGF, IL-6, IL-18, IL-10, CCL2
Measured: Baseline
Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity
Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests
Measured: Baseline
Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel
Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-α, PlGF, IL-6, IL-18, IL-10, CCL2
Measured: Baseline
Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel
Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests
Measured: Baseline
Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel
Measured: Baseline
Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery
Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests
Measured: Baseline
Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery
Measured: Baseline
Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery
Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-α, PlGF, IL-6, IL-18, IL-10, CCL2
Measured: Baseline
Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient
Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests
Measured: Baseline
Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient
Measured: Baseline
Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient
Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-α, PlGF, IL-6, IL-18, IL-10, CCL2
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start21 Jul 2023
- Primary completion21 Jul 2025 (estimated)
- Study completion21 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland, University College, London, Queen Mary University of London
- Responsible party
- Principal investigator, Mariusz Tomaniak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275399
- Sponsor's protocol ID
- INTERFORCE
- Acronym
- INTERFORCE
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Morphometric, Functional, Biomechanical, and Biological Interactions Between Atherosclerotic Plaque and Blood Platelets Within the Stenosed Coronary Artery in Vivo: a Prospective Study
- ClinicalTrials.gov ID
- NCT06275399
- Acronym / sponsor ID
- INTERFORCE / INTERFORCE
- Conditions
- Chronic Coronary Syndrome, Atherosclerosis
- Keywords
- Optical Coherence Tomography, vFFR, Shear Rate, Impedance aggregometry, Shear stress, Proteomic, Metabolomic, Computational fluid dynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- National Science Centre, Poland, University College, London, Queen Mary University of London
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 21 Jul 2026 (estimated)
- First posted
- 23 Feb 2024 (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 main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery.
Detailed description
The biomechanical forces, including shear rate and shear stress exerted by circulating blood on the coronary wall and on circulating blood elements have been reported to contribute to the processes of plaque destabilization and thrombosis. Reliable estimation of shear (shear rate and shear stress) acting in vivo within the coronary artery has now become possible using imaging data and computational fluid dynamics techniques. The changing microenvironment of the plaque has a crucial role in the biochemical processes involved in remodeling the plaque itself. In this prospective, single-center study a total of 105 patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis (30% - 90%) amenable to OCT imaging (according to the operator's judgment).
The groups will be assessed at the time of angiography with:
- OCT examination for precise evaluation of plaque morphology within the coronary stenosis
- Computational fluid dynamics with vFFR and estimation of value and distribution of shear rate and shear stress
- Impedance aggregometry-based platelet reactivity
- Single-particle high-resolution flow cytometry analysis of platelet-derived microvesicles and small extracellular vesicles (sEVs) as well as additional platelet activation (P-selectin, annexin-V) and inflammatory biomarkers
- Proteomic and metabolomic characterization - in the subset of patients Biomarker assessment will be done in the blood sampled directly from coronary artery (proximal and distal segment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging | – | Diagnostic Test: OCT examination, Diagnostic Test: Blood sampling, Diagnostic Test: Assessment of vFFR and shear stress parametersPatients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging. The groups will be assessed at the time of angiography with: * OCT for evaluation of plaque morphology within the coronary stenosis * Computational fluid dynamics with vFFR and estimation of value and distribution of shear rate and shear stress * Impedance aggregometry based platelet reactivity * Single-particle high-resolution flow cytometry analysis of pMVs and sEVs as well as additional platelet activation and inflammatory biomarkers * Proteomic and metabolomic characterization - in the subset of patients Biomarker assessment will be done in the blood sampled directly from coronary artery (proximal and distal segment) arteries. Shear rate/shear stress distribution and biomarkers profile will be compared between the stenotic vessel and the non-stenotic vessel (stenoses <30%) in the same patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis (30% - 90%) amenable to OCT imaging (according to the operator's judgment).
Key inclusion criteria (3 listed)
- Chronic coronary syndrome
- Angiographically confirmed coronary stenosis (30% - 90%)
- Amenable to OCT imaging
Key exclusion criteria (10 listed)
- Cardiogenic shock
- ST-segment elevation or non-ST-segment elevation myocardial infarction
- Active bleeding
- Left main coronary artery disease
- Multivessel disease
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 |
|---|---|---|
| OCT examinationOCT examination for precise evaluation of plaque morphology within the coronary stenosis. | Diagnostic test | Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging |
| Blood samplingBlood sampling directly from coronary artery (proximal and distal segment) arteries | Diagnostic test | Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging |
| Assessment of vFFR and shear stress parametersThe procedure is based on non-invasive assessment of vFFR and shear stress parameters with dedicated software, deriving parameters directly from coronary angiography with the calculation based on the computational fluid dynamics | Diagnostic test | Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging |
Primary outcome
Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery.
Time frame: Baseline
14 secondary outcomes
Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery
Time frame: Baseline
Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery
Time frame: Baseline
Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs
Time frame: Baseline
Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers
Time frame: Baseline
Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity
Time frame: Baseline
Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel
Time frame: Baseline
Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel
Time frame: Baseline
Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel
Time frame: Baseline
Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery
Time frame: Baseline
Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery
Time frame: Baseline
Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery
Time frame: Baseline
Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient
Time frame: Baseline
Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient
Time frame: Baseline
Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Adrian Bednarek contact
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 Chronic Coronary Syndrome and Atherosclerosis, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 10 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 23 Feb 2024. 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 Poland. 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 Mariusz Tomaniak (+48 22 5991951, mariusz.tomaniak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery. (time frame: Baseline). 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 23 Feb 2024.