Stable AnginaRELATENCT04048005
Relationship Between Fractional Flow Reserve/ Instantaneous Wave Free Ratio and Endothelial Wall Shear Stress
An observational study of Stable Angina and Acute Coronary Syndrome, run by A.O.U. Città della Salute e della Scienza at 3 sites in Italy.
Trial summary
This study, designed as a retrospective registry, aims to investigate the relationship and potential interplay between fractional flow reserve (FFR) or instantaneous waves free ratio (iFR) with wall shear stress (WSS) in the context of intermediate coronary stenosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stable Angina, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Fractional flow reserve
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - The study will include any patient referred for coronary angiography at each involved center and with a subsequent invasive physiological assessment performed with FFR or iFR (or both) at operating physician's discretion on intermediate coronary stenosis (diameter of stenosis ranging from 30-90% at visual angiographic estimation).
Who may be able to join
- Angiography performed for suspected symptom/ischemia-driven stable coronary artery disease or for acute coronary syndromes
- At least one lesion with 30-90% diameter stenosis at invasive angiography with FFR/iFR assessed (for patients with acute coronary syndromes, the invasive assessment will be performed on non-culprit stenosis
- Patient informed consent for data collection and publication in anonymous studies
Who cannot join
- Quality of angiographic frames not sufficient for 3D-reconstruction and/or computations
- Patients denying informed consent
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Enrolling by invitation
Ospedale di Rivoli
Rivoli, 10098
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10126
Fabrizio D'Ascenzo, MD, +390116336023, fabrizio.dascenzo@gmail.com
- Enrolling by invitation
Ospedale San Giovanni Bosco
Torino, 10144
About this study
Official title: RELATionship bEtween Lesion-level Invasive Fractional Flow Reserve AND Endothelial Wall Shear Stress the RELATE FFR and WSS Study
This study, designed as a retrospective registry, aims to investigate the relationship and potential interplay between fractional flow reserve (FFR) or instantaneous waves free ratio (iFR) with wall shear stress (WSS) in the context of intermediate coronary stenosis.
Read the detailed description
BACKGROUND AND RATIONALE Despite great advances in atherothrombosis science, the complex interplay of factors leading to plaque progression remains elusive. Specifically, the dynamics leading a stable plaque towards rupture and over imposed thrombosis are largely speculative. Wall shear stress (WSS), the mechanical force elicited by blood flow on the vessel walls, is emerging as a potent trigger of bio-humoral processes eventually leading to endothelial damage, plaque progression and destabilization.
Fractional flow reserve (FFR), assessing the aggregate hemodynamical significance of a stenosis on the subtended myocardium, stratifies the risk of major adverse cardiovascular events and reduces their occurrence when used to guide revascularization. While this event reduction is mainly driven by ischemia-caused urgent revascularization, it is emerging that FFR-guided revascularization may also reduce myocardial infarction.
While the physiological relationship between a lesion's FFR and resulting ischemia in the subtended myocardium is intuitive, the mechanisms linking FFR to atherothrombosis are less clearly defined.
Lesions with lower FFR are associated with adverse atherosclerotic plaque characteristics (APCs), however, the causative nexus of this relationship is not well established. It has been proposed both that the physiological base for this relation underlies in disturbed lesion hemodynamics, occurring at a greater extent as the degree of functional obstruction increases (i.e. FFR reduction drives APCs), and that APCs directly impair the vessel's vasodilatory reserve resulting in detrimental hyperemic perfusion (i.e. APCs drive FFR reduction).
WSS measures the regional tangential hemodynamic forces produced by viscous blood flow on the endothelium, which is established drivers of plaque progression and transformation toward an adverse plaque phenotype. Intriguingly, WSS may thus represent the missing link between FFR and atherothrombosis.
Few studies have focused on the interplay of FFR and WSS and the provided results are inconclusive (9, 10). This relation remains thus to be fully characterized.
This study will investigate the association of aggregate with regional hemodynamic forces as defined by the lesion-level relation of FFR or instantaneous wave-free ratio (iFR) and regional WSS across the lesion.
STUDY DESIGN This is a retrospective observational multi-center study, including consecutive patients who underwent coronary angiography at for symptom/ischemia-driven, suspected stable coronary artery disease or for acute coronary syndromes (ACS) with evidence of at least one lesion with 30-90% diameter-stenosis, that underwent subsequent iFR/FFR assessment.
Coronary angiography of the screened patients will be retrospectively evaluated by an experienced Interventional cardiologist and, if deemed suitable for baseline angiographic reconstruction will be included in this registry.
3-dimensional (3D) geometric reconstructions of each patient's target vessel will be created by using end-diastolic angiographic projections at least 25° apart. Computational fluid dynamics models will be applied to derive regional WSS values across the stenosis.
Clinical baseline characteristics and angiographic features obtained by visual and functional assessment, and 3-D reconstruction and computation, along with major adverse cardiovascular events, will be collected in a dedicated electronic form.
The analysts performing angiographic 3-D reconstruction and WSS computations will be blinded to FFR/iFR values and clinical data.
STUDY ENDPOINTS This study will investigate the association of aggregate and regional hemodynamic forces as established by the lesion-level relation of FFR/iFR with regional WSS across the lesion.
The association of regional WSS with major cardiovascular adverse events at available follow-up will be further evaluated to assess if lesion-level WSS might predict overall patient-level outcomes (in case of more than one lesion for a single patient, the lesion with the highest WSS will be considered for this analysis).
- Being tested
- Fractional flow reserve
- Medical subject headings
- Angina, Stable, Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserveDiagnostic test
Also called instantaneous wave free ratio
What is being measured
The primary outcome is the main question the study is designed to answer.
Wall shear stress (WSS) / Fractional flow reserve (FFR) or instantaneous wave free ratio (iFR)correlation
After 3-dimensional coronary reconstruction through dedicated software (Qangio XA 3D (MEDIS), WSS will be calculated through fluydodinamic equations across the entire coronary vessel and across coronary stenosis. WSS values predicting positive invasive FFR and iFR (according to their dichothomic established values of positivity, namely FFR < 0.8 and iFR < 0.89) measurements will be searched, along with any possible relationship between WSS and FFR/iFR as continuos values.
Measured: WSS will be calculated after 3D coronary reconstruction, within one year after the completion of retrospective enrollement
MACE (major adverse cardiovascular events)
The association of regional WSS with major cardiovascular adverse events at available follow-up will be further evaluated to assess if lesion-level WSS might predict overall patient-level outcomes
Measured: MACE will be evaluated for each patients through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Torino
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048005
- Sponsor's protocol ID
- RELATE FFR and WSS
- Acronym
- RELATE
- Status last verified
- Aug 2019
- First submitted
- 4 Aug 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ford TJ, Berry C, De Bruyne B, Yong ASC, Barlis P, Fearon WF, Ng MKC. Physiological Predictors of Acute Coronary Syndromes: Emerging Insights From the Plaque to the Vulnerable Patient. JACC Cardiovasc Interv. 2017 Dec 26;10(24):2539-2547. doi: 10.1016/j.jcin.2017.08.059.
PubMed 29268883Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.
PubMed 21788584Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973.
PubMed 25323250De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
PubMed 22924638Zimmermann FM, Omerovic E, Fournier S, Kelbaek H, Johnson NP, Rothenbuhler M, Xaplanteris P, Abdel-Wahab M, Barbato E, Hofsten DE, Tonino PAL, Boxma-de Klerk BM, Fearon WF, Kober L, Smits PC, De Bruyne B, Pijls NHJ, Juni P, Engstrom T. Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data. Eur Heart J. 2019 Jan 7;40(2):180-186. doi: 10.1093/eurheartj/ehy812.
PubMed 30596995Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
PubMed 29785878Driessen RS, Stuijfzand WJ, Raijmakers PG, Danad I, Min JK, Leipsic JA, Ahmadi A, Narula J, van de Ven PM, Huisman MC, Lammertsma AA, van Rossum AC, van Royen N, Knaapen P. Effect of Plaque Burden and Morphology on Myocardial Blood Flow and Fractional Flow Reserve. J Am Coll Cardiol. 2018 Feb 6;71(5):499-509. doi: 10.1016/j.jacc.2017.11.054.
PubMed 29406855Kumar A, Thompson EW, Lefieux A, Molony DS, Davis EL, Chand N, Fournier S, Lee HS, Suh J, Sato K, Ko YA, Molloy D, Chandran K, Hosseini H, Gupta S, Milkas A, Gogas B, Chang HJ, Min JK, Fearon WF, Veneziani A, Giddens DP, King SB 3rd, De Bruyne B, Samady H. High Coronary Shear Stress in Patients With Coronary Artery Disease Predicts Myocardial Infarction. J Am Coll Cardiol. 2018 Oct 16;72(16):1926-1935. doi: 10.1016/j.jacc.2018.07.075.
PubMed 30309470Lee KE, Kim GT, Lee JS, Chung JH, Shin ES, Shim EB. A patient-specific virtual stenotic model of the coronary artery to analyze the relationship between fractional flow reserve and wall shear stress. Int J Cardiol. 2016 Nov 1;222:799-805. doi: 10.1016/j.ijcard.2016.07.153. Epub 2016 Aug 3.
PubMed 27522378
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELATionship bEtween Lesion-level Invasive Fractional Flow Reserve AND Endothelial Wall Shear Stress the RELATE FFR and WSS Study
- ClinicalTrials.gov ID
- NCT04048005
- Acronym / sponsor ID
- RELATE / RELATE FFR and WSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- Politecnico di Torino
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Aug 2019 (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.
This study, designed as a retrospective registry, aims to investigate the relationship and potential interplay between fractional flow reserve (FFR) or instantaneous waves free ratio (iFR) with wall shear stress (WSS) in the context of intermediate coronary stenosis.
Detailed description
BACKGROUND AND RATIONALE Despite great advances in atherothrombosis science, the complex interplay of factors leading to plaque progression remains elusive. Specifically, the dynamics leading a stable plaque towards rupture and over imposed thrombosis are largely speculative. Wall shear stress (WSS), the mechanical force elicited by blood flow on the vessel walls, is emerging as a potent trigger of bio-humoral processes eventually leading to endothelial damage, plaque progression and destabilization.
Fractional flow reserve (FFR), assessing the aggregate hemodynamical significance of a stenosis on the subtended myocardium, stratifies the risk of major adverse cardiovascular events and reduces their occurrence when used to guide revascularization. While this event reduction is mainly driven by ischemia-caused urgent revascularization, it is emerging that FFR-guided revascularization may also reduce myocardial infarction.
While the physiological relationship between a lesion's FFR and resulting ischemia in the subtended myocardium is intuitive, the mechanisms linking FFR to atherothrombosis are less clearly defined.
Lesions with lower FFR are associated with adverse atherosclerotic plaque characteristics (APCs), however, the causative nexus of this relationship is not well established. It has been proposed both that the physiological base for this relation underlies in disturbed lesion hemodynamics, occurring at a greater extent as the degree of functional obstruction increases (i.e. FFR reduction drives APCs), and that APCs directly impair the vessel's vasodilatory reserve resulting in detrimental hyperemic perfusion (i.e. APCs drive FFR reduction).
WSS measures the regional tangential hemodynamic forces produced by viscous blood flow on the endothelium, which is established drivers of plaque progression and transformation toward an adverse plaque phenotype. Intriguingly, WSS may thus represent the missing link between FFR and atherothrombosis.
Few studies have focused on the interplay of FFR and WSS and the provided results are inconclusive (9, 10). This relation remains thus to be fully characterized.
This study will investigate the association of aggregate with regional hemodynamic forces as defined by the lesion-level relation of FFR or instantaneous wave-free ratio (iFR) and regional WSS across the lesion.
STUDY DESIGN This is a retrospective observational multi-center study, including consecutive patients who underwent coronary angiography at for symptom/ischemia-driven, suspected stable coronary artery disease or for acute coronary syndromes (ACS) with evidence of at least one lesion with 30-90% diameter-stenosis, that underwent subsequent iFR/FFR assessment.
Coronary angiography of the screened patients will be retrospectively evaluated by an experienced Interventional cardiologist and, if deemed suitable for baseline angiographic reconstruction will be included in this registry.
3-dimensional (3D) geometric reconstructions of each patient's target vessel will be created by using end-diastolic angiographic projections at least 25° apart. Computational fluid dynamics models will be applied to derive regional WSS values across the stenosis.
Clinical baseline characteristics and angiographic features obtained by visual and functional assessment, and 3-D reconstruction and computation, along with major adverse cardiovascular events, will be collected in a dedicated electronic form.
The analysts performing angiographic 3-D reconstruction and WSS computations will be blinded to FFR/iFR values and clinical data.
STUDY ENDPOINTS This study will investigate the association of aggregate and regional hemodynamic forces as established by the lesion-level relation of FFR/iFR with regional WSS across the lesion.
The association of regional WSS with major cardiovascular adverse events at available follow-up will be further evaluated to assess if lesion-level WSS might predict overall patient-level outcomes (in case of more than one lesion for a single patient, the lesion with the highest WSS will be considered for this analysis).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - The study will include any patient referred for coronary angiography at each involved center and with a subsequent invasive physiological assessment performed with FFR or iFR (or both) at operating physician's discretion on intermediate coronary stenosis (diameter of stenosis ranging from 30-90% at visual angiographic estimation).
Key inclusion criteria (3 listed)
- Angiography performed for suspected symptom/ischemia-driven stable coronary artery disease or for acute coronary syndromes
- At least one lesion with 30-90% diameter stenosis at invasive angiography with FFR/iFR assessed (for patients with acute coronary syndromes, the invasive assessment will be performed on non-culprit stenosis
- Patient informed consent for data collection and publication in anonymous studies
Key exclusion criteria (2 listed)
- Quality of angiographic frames not sufficient for 3D-reconstruction and/or computations
- Patients denying informed consent
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 |
|---|---|---|
| Fractional flow reserveAlso: instantaneous wave free ratio | Diagnostic test | – |
Primary outcome
Wall shear stress (WSS) / Fractional flow reserve (FFR) or instantaneous wave free ratio (iFR)correlation
Time frame: WSS will be calculated after 3D coronary reconstruction, within one year after the completion of retrospective enrollement
After 3-dimensional coronary reconstruction through dedicated software (Qangio XA 3D (MEDIS), WSS will be calculated through fluydodinamic equations across the entire coronary vessel and across coronary stenosis. WSS values predicting positive invasive FFR and iFR (according to their dichothomic established values of positivity, namely FFR < 0.8 and iFR < 0.89) measurements will be searched, along with any possible relationship between WSS and FFR/iFR as continuos values.
MACE (major adverse cardiovascular events)
Time frame: MACE will be evaluated for each patients through study completion, an average of 1 year
The association of regional WSS with major cardiovascular adverse events at available follow-up will be further evaluated to assess if lesion-level WSS might predict overall patient-level outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 29268883Ford TJ, Berry C, De Bruyne B, Yong ASC, Barlis P, Fearon WF, Ng MKC. Physiological Predictors of Acute Coronary Syndromes: Emerging Insights From the Plaque to the Vulnerable Patient. JACC Cardiovasc Interv. 2017 Dec 26;10(24):2539-2547. doi: 10.1016/j.jcin.2017.08.059.
- Background: PubMed 21788584Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.
- Background: PubMed 25323250Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973.
- Background: PubMed 22924638De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
- Background: PubMed 30596995Zimmermann FM, Omerovic E, Fournier S, Kelbaek H, Johnson NP, Rothenbuhler M, Xaplanteris P, Abdel-Wahab M, Barbato E, Hofsten DE, Tonino PAL, Boxma-de Klerk BM, Fearon WF, Kober L, Smits PC, De Bruyne B, Pijls NHJ, Juni P, Engstrom T. Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data. Eur Heart J. 2019 Jan 7;40(2):180-186. doi: 10.1093/eurheartj/ehy812.
- Background: PubMed 29785878Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
- Background: PubMed 29406855Driessen RS, Stuijfzand WJ, Raijmakers PG, Danad I, Min JK, Leipsic JA, Ahmadi A, Narula J, van de Ven PM, Huisman MC, Lammertsma AA, van Rossum AC, van Royen N, Knaapen P. Effect of Plaque Burden and Morphology on Myocardial Blood Flow and Fractional Flow Reserve. J Am Coll Cardiol. 2018 Feb 6;71(5):499-509. doi: 10.1016/j.jacc.2017.11.054.
- Background: PubMed 30309470Kumar A, Thompson EW, Lefieux A, Molony DS, Davis EL, Chand N, Fournier S, Lee HS, Suh J, Sato K, Ko YA, Molloy D, Chandran K, Hosseini H, Gupta S, Milkas A, Gogas B, Chang HJ, Min JK, Fearon WF, Veneziani A, Giddens DP, King SB 3rd, De Bruyne B, Samady H. High Coronary Shear Stress in Patients With Coronary Artery Disease Predicts Myocardial Infarction. J Am Coll Cardiol. 2018 Oct 16;72(16):1926-1935. doi: 10.1016/j.jacc.2018.07.075.
- Background: PubMed 27522378Lee KE, Kim GT, Lee JS, Chung JH, Shin ES, Shim EB. A patient-specific virtual stenotic model of the coronary artery to analyze the relationship between fractional flow reserve and wall shear stress. Int J Cardiol. 2016 Nov 1;222:799-805. doi: 10.1016/j.ijcard.2016.07.153. Epub 2016 Aug 3.
- Individual participant dataSharing planned: Undecided
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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.
AOU Città della Salute e della Scienza di Torino
Torino, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Acute Coronary Syndrome, run by A.O.U. Città della Salute e della Scienza at 3 sites 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 3 inclusion and 2 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wall shear stress (WSS) / Fractional flow reserve (FFR) or instantaneous wave free ratio (iFR)correlation (time frame: WSS will be calculated after 3D coronary reconstruction, within one year after the completion of retrospective enrollement). 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 NCT04048005, which also lists 9 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 7 Aug 2019.