OCT Measures Predicting FFR
OMEF
OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)
1 other identifier
observational
500
1 country
1
Brief Summary
Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique. Objectives:
- 1.Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR.
- 2.Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2018
CompletedFirst Submitted
Initial submission to the registry
April 23, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedJune 29, 2018
June 1, 2018
14 days
April 23, 2018
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
OCT measures predicting FFR - mean lumen area
ICL mean lumen area (MLA)
1 day
OCT measure predicting FFR - area stenosis
ICL percentage area stenosis (AS)
1 day
OCT measure predicting FFR - thrombus or ulceration
Presence of thrombus or ulceration at the level of ICL
1 day
Secondary Outcomes (1)
Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG)
1 year
Study Arms (1)
Optical coherence tomography (OCT)
Interventions
Eligibility Criteria
Stable or unstable patients with intermediate coronary lesions who underwent both FFR and OCT assessment of the same lesion
You may qualify if:
- Patients with angiographically-intermediate coronary lesion
- Patients who underwent both FFR and OCT assessment of the same lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Related Publications (1)
Lombardi M, Vergallo R, Costantino A, Bianchini F, Kakuta T, Pawlowski T, Leone AM, Sardella G, Agostoni P, Hill JM, De Maria GL, Banning AP, Roleder T, Belkacemi A, Trani C, Burzotta F. Development of machine learning models for fractional flow reserve prediction in angiographically intermediate coronary lesions. Catheter Cardiovasc Interv. 2024 Sep;104(3):472-482. doi: 10.1002/ccd.31167. Epub 2024 Aug 1.
PMID: 39091119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 23, 2018
First Posted
June 29, 2018
Study Start
October 16, 2017
Primary Completion
October 30, 2017
Study Completion
February 18, 2018
Last Updated
June 29, 2018
Record last verified: 2018-06