Fluid-dynamics in Bifurcation PCI (FORECAST)

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:

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 Overview

• Status: Unknown
• Conditions: Atherosclerosis, Coronary
• Intervention / Treatment: Procedure: Coronary angiography and optical coherence tomography

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria

• 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).

Exclusion Criteria

• 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%.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients with bifurcated coronary lesions treated by percutaneous coronary interventions.	Procedure: Coronary angiography and optical coherence tomography; 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
Cohort B; Patients with untreated bifurcated coronary lesions.	Procedure: Coronary angiography and optical coherence tomography; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1,6,12,18,24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1,6,12,18,24 and 36 months
Bifurcated lesion angiographic failure	Cardiac death; MI; TVR; Definite or probable stent thrombosis	1,6,12,18,24 and 36 months

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Francesco Burzotta, MD, Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (ACTUAL): June 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Percutaneous coronary interventions; Coronary atherosclerosis in bifurcations
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 01012017