INTegrated Assessment of intERmediate Coronary Stenoses by Fractional Flow rEserve (FFR) and Near-infraREd Spectroscopy (NIRS)

NCT02985112 | Unknown

• 1 other identifier: USL9-2015-007-NIRS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Revascularization of borderline coronary stenoses (40-70%) is usually driven by fractional flow reserve (FFR) which expresses the physiological significance of a lesion and tells the operator whether PCI may reduce the rate of adverse events as compared to medical therapy. Coronary stenoses with FFR value \< 0.80 are indeed associated with a higher rate of adverse event and requires coronary revascularization whereas lesions with FFR \> 0.80 show an excellent prognosis which cannot be improved by coronary stenting. Such a predictive value of FFR is theoretically based only on the degree of myocardial ischemia downstream from a given coronary stenosis: however, also plaque composition may play a crucial role in triggering future events especially in patients affected by acute coronary syndrome. Differences in plaque composition between FFR-positive and FFR negative lesions have never been assessed. Intracoronary Near-InfraRed Spectroscopy (NIRS) identifies lipid rich plaques that can potentially cause acute events. The aim of this study is to compare the lipid content expressed by LCBI (Lipid Core Burden Index) between functionally significant (FFR \< 0.80) and non-significant (FFR \> 0.80) stenoses in patients undergoing coronary angiography because of stable CAD and non-ST elevation acute coronary syndromes. This is an observational, prospective, multicentric study where we plan to collect 150 coronary lesions.

Conditions

Borderline Coronary Stenoses Assessment, Fractional Flow Reserve, Plaque Composition

Outcome Measures

Primary Outcomes (1)

• Percentage of coronary plaques with LCBImax > 400 in lesions with FFR > 0.80 vs lesions with FFR < 0.80.

  Baseline

Study Arms (2)

Patients with FFR > 0.80

Group of patients with physiologically non-significant coronary stenoses who will not undergo coronary revascularization

Device: FFR and IVUS-NIRS

Patients with FFR < 0.80

Group of patients with physiologically significant coronary stenoses who will undergo coronary revascularization

Device: FFR and IVUS-NIRS

Interventions

FFR and IVUS-NIRS DEVICE

Patients with FFR < 0.80; Patients with FFR > 0.80

Eligibility Criteria

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

Study Population

Subjects undergoing coronary angiography for stable CAD and non-ST-segment elevation acute myocardial infarction (NSTEMI) and unstable angina will be enrolled. Patients included must have evidence of at least one angiographically borderline stenosis (≥ 40, \<70% by Quantitative Coronary Angiography, QCA) with normal antegrade flow (TIMI 3). The index lesion will be evaluated by FFR; afterwards, plaque composition and lesion characteristics will be evaluated by IVUS - NIRS. PCI will be performed according to current guidelines on myocardial revascularization1. Patients with hemodynamic instability, ST-segment-elevation myocardial infarction, known allergy to antiplatelet or anticoagulant drugs, history of previous CABG, significant left main disease, life expectancy \< 1 year, severe renal failure, malignancy, scheduled valve surgery, inability to provide informed consent, known bronchial asthma, age \< 18 will be excluded.

You may qualify if:

• Subjects undergoing coronary angiography for stable CAD and non-ST-segment elevation acute myocardial infarction (NSTEMI) and unstable angina will be enrolled. Patients included must have evidence of at least one angiographically borderline stenosis (≥ 40, \<70% by Quantitative Coronary Angiography, QCA) with normal antegrade flow (TIMI 3). The index lesion will be evaluated by FFR; afterwards, plaque composition and lesion characteristics will be evaluated by IVUS - NIRS. PCI will be performed according to current guidelines on myocardial revascularization1.

You may not qualify if:

• Patients with hemodynamic instability, ST-segment-elevation myocardial infarction, known allergy to antiplatelet or anticoagulant drugs, history of previous CABG, significant left main disease, life expectancy \< 1 year, severe renal failure, malignancy, scheduled valve surgery, inability to provide informed consent, known bronchial asthma.

Sponsors & Collaborators

• S.M. Misericordia Hospital: lead
• San Giovanni Addolorata Hospital: collaborator

Study Sites (1)

Cardiology Unit, Misericordia Hospital

Grosseto, Italy, 58100, Italy

RECRUITING

Related Publications (1)

• Picchi A, Campo G, Misuraca L, Baratta P, Biancofiore A, Calabria P, Massoni A, Limbruno U. INTegrated Assessment of intERmediate Coronary Stenoses by Fractional Flow rEserve and Near-infraREd Spectroscopy: The INTERFERE Study. J Clin Med. 2025 Sep 25;14(19):6769. doi: 10.3390/jcm14196769.

  PMID: 41095849 DERIVED

Central Study Contacts

Andrea Picchi

CONTACT

+390564483465; andre.picchi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 12, 2016

Record last verified: 2016-12

Locations

IT (1)