Atherosclerosis, CoronaryFORECASTNCT03174418
Fluid-dynamics in Bifurcation PCI
An observational study of Atherosclerosis, Coronary, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Investigator-initiated, international, multicentre, observational study with two cohorts. The two study cohorts will be: Cohort A: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary
- What is being tested?
- Coronary angiography and optical coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2017to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable or unstable coronary artery disease due to atherosclerosis involving a major bifurcation site, who undergo diagnostic or interventional invasive percutaneous coronary procedures with the use of optical coherence tomography (OCT) based on operator's choice.
Who may be able to join
- Patients with stable or unstable coronary artery disease;
- TIMI 3 on both MV and SB;
- MV visual diameter > 2.5 mm;
- SB visual diameter > 2.0 mm;
- Documentation of angiographically-critical (visually estimated percentage diameter stenosis ≥80% <100%) coronary lesion treated by PCI and underwent post-PCI OCT assessment or angiographically-intermediate (visually estimated percentage diameter stenosis ranging between 30-80%) lesion in the MV considered suitable for conservative management (myocardial revascularization not planned).
Who cannot join
- Age < 18 years or impossibility to give informed consent.
- Female sex with child-bearing potential.
- Life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc.).
- Ascertained or suspected contraindications to prolonged (up to 6 month) double antiplatelet therapy.
- Known hypersensitivity to aspirin, heparin, contrast dye, sirolimus, everolimus, zotarolimus, cobalt, chromium, nickel, tungsten acrylic, and fluoro-polymers.
- Poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
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- Recent (< 48 hours) ST-segment elevation myocardial infarction.
- Severe myocardial hypertrophy (interventricular septum thickness > 15 mm, ECG Sokolow's criteria fulfilled).
- Severe valvular heart disease.
- Significant platelet count alteration (<100,000 cells/mm3 or > 700,000 cells/mm3).
- Gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks.
- History of clotting pathology.
- Advance renal failure with glomerular filtration rate < 30 ml/min (Cockcroft-Gault equation)
- Left main lesion.
- Target bifurcation located on a distal coronary segment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Roma, 00168
Francesco Burzotta, MD, PhD, +39 349-429-5290, francesco.burzotta@unicatt.it
About this study
Official title: A Multicentre Prospective Study on the Role of Fluid Dynamics OCT-based REconstruction of Coronary Atherosclerosis in bifurcationS to Predict ouTcome
Investigator-initiated, international, multicentre, observational study with two cohorts.
The two study cohorts will be:
Read more
Cohort A: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with bifurcated coronary lesions treated by PCI.
Cohort B: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with sub-critical bifurcated lesions managed conservatively.
Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the time-averaged WSS at the bifurcated lesion level by using computational fluid dynamics software.
Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in patients treated by PCI) images will be processed.
- Conditions
- Atherosclerosis, Coronary
- Being tested
- Coronary angiography and optical coherence tomography
- Keywords
- Optical coherence tomography, Percutaneous coronary interventions, Coronary atherosclerosis in bifurcations
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiography and optical coherence tomographyProcedure or surgery
Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the arterial time-averaged wall shear stress at the bifurcated lesion level
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients with bifurcated coronary lesions treated by percutaneous coronary interventions. Receives: Procedure: Coronary angiography and optical coherence tomography | |
| Cohort B | Patients with untreated bifurcated coronary lesions. Receives: Procedure: Coronary angiography and optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target bifurcation failure (TBF)
- Target bifurcated lesion-related major adverse coronary event (MACE) defined as the composite of:
- cardiac death
- myocardial infarction (MI) not clearly related with another vessel
- target vessel revascularization (TVR)
Measured: 1,6,12,18,24 and 36 months
Secondary outcomes (2)
Target vessel failure
- In the absence of target bifurcated lesion-related MACE, target bifurcated lesion angiographic failure defined, in patients treated by PCI, as: > 50% restenosis on the main vessel (MV) or TIMI (Thrombolysis In Myocardial Infarction) flow < 3 on the side branch (SB) at angiography eventually performed during the clinical course.
Measured: 1,6,12,18,24 and 36 months
Bifurcated lesion angiographic failure
- Cardiac death
- MI
- TVR
- Definite or probable stent thrombosis
Measured: 1,6,12,18,24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis, CoronaryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Burzotta, Catholic University of the Sacred Heart
- Investigators
- Francesco Burzotta, MD, Principal investigator, Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174418
- Sponsor's protocol ID
- 01012017
- Acronym
- FORECAST
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Study on the Role of Fluid Dynamics OCT-based REconstruction of Coronary Atherosclerosis in bifurcationS to Predict ouTcome
- ClinicalTrials.gov ID
- NCT03174418
- Acronym / sponsor ID
- FORECAST / 01012017
- Conditions
- Atherosclerosis, Coronary
- Keywords
- Optical coherence tomography, Percutaneous coronary interventions, Coronary atherosclerosis in bifurcations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 2 Jun 2017 (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.
Investigator-initiated, international, multicentre, observational study with two cohorts.
The two study cohorts will be:
Cohort A: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with bifurcated coronary lesions treated by PCI.
Cohort B: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with sub-critical bifurcated lesions managed conservatively.
Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the time-averaged WSS at the bifurcated lesion level by using computational fluid dynamics software.
Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in patients treated by PCI) images will be processed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Coronary angiography and optical coherence tomographyPatients with bifurcated coronary lesions treated by percutaneous coronary interventions. |
| Cohort B | – | Procedure: Coronary angiography and optical coherence tomographyPatients with untreated bifurcated coronary lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable or unstable coronary artery disease due to atherosclerosis involving a major bifurcation site, who undergo diagnostic or interventional invasive percutaneous coronary procedures with the use of optical coherence tomography (OCT) based on operator's choice.
Key inclusion criteria (5 listed)
- Patients with stable or unstable coronary artery disease;
- TIMI 3 on both MV and SB;
- MV visual diameter > 2.5 mm;
- SB visual diameter > 2.0 mm;
- Documentation of angiographically-critical (visually estimated percentage diameter stenosis ≥80% <100%) coronary lesion treated by PCI and underwent post-PCI OCT assessment or angiographically-intermediate (visually estimated percentage diameter stenosis ranging between 30-80%) lesion in the MV considered suitable for conservative management (myocardial revascularization not planned).
Key exclusion criteria (15 listed)
- Age < 18 years or impossibility to give informed consent.
- Female sex with child-bearing potential.
- Life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc.).
- Ascertained or suspected contraindications to prolonged (up to 6 month) double antiplatelet therapy.
- Known hypersensitivity to aspirin, heparin, contrast dye, sirolimus, everolimus, zotarolimus, cobalt, chromium, nickel, tungsten acrylic, and fluoro-polymers.
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 |
|---|---|---|
| Coronary angiography and optical coherence tomographyCoronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the arterial time-averaged wall shear stress at the bifurcated lesion level | Procedure or surgery | Cohort A, Cohort B |
Primary outcome
Target bifurcation failure (TBF)
Time frame: 1,6,12,18,24 and 36 months
- Target bifurcated lesion-related major adverse coronary event (MACE) defined as the composite of: * cardiac death * myocardial infarction (MI) not clearly related with another vessel * target vessel revascularization (TVR)
2 secondary outcomes
Target vessel failure
Time frame: 1,6,12,18,24 and 36 months
Bifurcated lesion angiographic failure
Time frame: 1,6,12,18,24 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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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.
Francesco Burzotta, MD principal investigator
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
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 Atherosclerosis, Coronary, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 5 inclusion and 15 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 2 Jun 2017. 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 Italy. 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 Francesco Burzotta, MD (+39 3494295290, francesco.burzotta@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target bifurcation failure (TBF) (time frame: 1,6,12,18,24 and 36 months). 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 2 Jun 2017.