Relationship Between Fractional Flow Reserve/ Instantaneous Wave Free Ratio and Endothelial Wall Shear Stress

NCT04048005 | Unknown

• 1 other identifier: RELATE FFR and WSS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stable Angina; Acute Coronary Syndrome; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Fractional flow reserve DIAGNOSTIC_TEST

Also known as: instantaneous wave free ratio

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• Quality of angiographic frames not sufficient for 3D-reconstruction and/or computations
• Patients denying informed consent

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• Politecnico di Torino: collaborator

Study Sites (3)

Ospedale di Rivoli

Rivoli, 10098, Italy

ENROLLING BY INVITATION

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

Ospedale San Giovanni Bosco

Torino, 10144, Italy

ENROLLING BY INVITATION

Related Publications (9)

• 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.

  PMID: 29268883 BACKGROUND

• 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.

  PMID: 21788584 BACKGROUND

• Johnson 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.

  PMID: 25323250 BACKGROUND

• De 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.

  PMID: 22924638 BACKGROUND

• Zimmermann 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.

  PMID: 30596995 BACKGROUND

• Xaplanteris 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.

  PMID: 29785878 BACKGROUND

• Driessen 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.

  PMID: 29406855 BACKGROUND

• 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.

  PMID: 30309470 BACKGROUND

• 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.

  PMID: 27522378 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Acute Coronary Syndrome; Coronary Artery Disease

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 7, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

IT (3)