Coronary DiseaseOMEFNCT03573388
OCT Measures Predicting FFR
An observational study of Coronary Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Optical coherence tomography (OCT)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2017to 18 Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable or unstable patients with intermediate coronary lesions who underwent both FFR and OCT assessment of the same lesion
Who may be able to join
- Patients with angiographically-intermediate coronary lesion
- Patients who underwent both FFR and OCT assessment of the same lesion
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Roma, 00168
About this study
Official title: OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)
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:
Read more
- Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR.
- Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR.
Study design: multicentre, international, individual patient's level data pooled analysis.
Read the detailed description
Principal investigators that enrolled stable or unstable patients with ICL who underwent both FFR and OCT assessment of the same lesion, will be contacted to participate the study. Agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, OCT and FFR parameters.
Collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of CAD, clinical presentation, previous PCI, previous MI, previous CABG, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (QCA% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, MLA, area stenosis at OCT, FFR protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.
- Conditions
- Coronary Disease
- Being tested
- Optical coherence tomography (OCT)
- Keywords
- Intermediate coronary lesions, Fractional flow reserve, Optical coherence tomography
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography (OCT)Device
Lesion OCT assessment
| Study group | Role | What they receive |
|---|---|---|
| Optical coherence tomography (OCT) | Not described Receives: Device: Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT measures predicting FFR - mean lumen area
ICL mean lumen area (MLA)
Measured: 1 day
OCT measure predicting FFR - area stenosis
ICL percentage area stenosis (AS)
Measured: 1 day
OCT measure predicting FFR - thrombus or ulceration
Presence of thrombus or ulceration at the level of ICL
Measured: 1 day
Secondary outcomes (1)
Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG)
Major Adverse Cardiac Events (MACE) defined as the composite of:
- cardiac death (any death not clearly attributed to non cardiac causes)
- (spontaneous) myocardial infarction (MI)
- surgical or percutaneous coronary revascularization of the target lesion (PCI o CABG)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start16 Oct 2017
- Primary completion30 Oct 2017
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Burzotta, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573388
- Sponsor's protocol ID
- 20042018
- Acronym
- OMEF
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
Publications
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.
PubMed 39091119
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)
- ClinicalTrials.gov ID
- NCT03573388
- Acronym / sponsor ID
- OMEF / 20042018
- Conditions
- Coronary Disease
- Keywords
- Intermediate coronary lesions, Fractional flow reserve, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 29 Jun 2018 (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.
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:
- Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR.
- Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR.
Study design: multicentre, international, individual patient's level data pooled analysis.
Detailed description
Principal investigators that enrolled stable or unstable patients with ICL who underwent both FFR and OCT assessment of the same lesion, will be contacted to participate the study. Agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, OCT and FFR parameters.
Collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of CAD, clinical presentation, previous PCI, previous MI, previous CABG, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (QCA% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, MLA, area stenosis at OCT, FFR protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical coherence tomography (OCT) | – | Device: Optical coherence tomography (OCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable or unstable patients with intermediate coronary lesions who underwent both FFR and OCT assessment of the same lesion
Key inclusion criteria (2 listed)
- Patients with angiographically-intermediate coronary lesion
- Patients who underwent both FFR and OCT assessment of the same lesion
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Optical coherence tomography (OCT)Lesion OCT assessment | Device | Optical coherence tomography (OCT) |
Primary outcome
OCT measures predicting FFR - mean lumen area
Time frame: 1 day
ICL mean lumen area (MLA)
OCT measure predicting FFR - area stenosis
Time frame: 1 day
ICL percentage area stenosis (AS)
OCT measure predicting FFR - thrombus or ulceration
Time frame: 1 day
Presence of thrombus or ulceration at the level of ICL
1 secondary outcome
Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 39091119Lombardi 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Catholic University of the Sacred Heart at 1 site 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT measures predicting FFR - mean lumen area (time frame: 1 day). The study lists 3 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 NCT03573388, which also lists 1 linked publication.
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 29 Jun 2018.