Coronary Artery Disease Clinical Trial
— RELATEOfficial title:
RELATionship bEtween Lesion-level Invasive Fractional Flow Reserve AND Endothelial Wall Shear Stress the RELATE FFR and WSS Study
Verified date | August 2019 |
Source | Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Quality of angiographic frames not sufficient for 3D-reconstruction and/or computations - Patients denying informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale di Rivoli | Rivoli | |
Italy | AOU Città della Salute e della Scienza di Torino | Torino | |
Italy | Ospedale San Giovanni Bosco | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino | Politecnico di Torino |
Italy,
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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. Review. — View Citation
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Kumar 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. — View Citation
Lee 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. — View Citation
Samady 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. — View Citation
Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrøm T, Kääb S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Fröbert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbühler M, Jüni 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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | WSS will be calculated after 3D coronary reconstruction, within one year after the completion of retrospective enrollement | |
Primary | 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 | MACE will be evaluated for each patients through study completion, an average of 1 year |
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