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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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.

Detailed Summary:

Background Objective of percutaneous coronary intervention (PCI) is the treatment of angiographically significant coronary stenoses in patients affected by stable or unstable coronary syndromes 1. When we face an intermediate stenosis (percentage diameter stenosis between 40% and 70%), revascularization is guided by the presence of inducible myocardial ischemia, detected by non - invasive stress tests or by assessment of fractional flow reserve (FFR). FFR is an index of the physiological significance of a coronary stenosis and is defined as the ratio of maximal blood flow in a stenotic artery to normal maximal flow. An FFR value of 0.80 or less identifies ischemia-causing coronary stenoses with an accuracy of more than 90%. FFR is a very accurate tool to identify functionally significant stenoses and to predict cardiovascular events in patients with stable coronary artery disease (CAD) and solid evidences demonstrate that PCI of lesions with FFR > 0.80 can be safely deferred (incidence of MACE < 1% with medical treatment only). Conversely, stenoses with an FFR <0.80 have a poor prognosis and require treatment by PCI 2-4. The afore-mentioned indications come from studies that mainly involved patients affected by stable CAD, but the role of FFR in the setting of acute coronary sindrome (ACS) is less clear. Hakeem et al. have recently shown that deferring percutaneous coronary intervention on the basis of non-ischemic FFR in patients with an initial presentation of ACS is associated with significantly worse outcomes than stable patients5.

FFR indeed has the ability to identify vessels with reduced coronary flow, but cannot detect atherosclerotic plaques with unstable features, which may present without flow limitation (FFR > 0.80) but can cause acute coronary events 6, 7. Since the prevalence of features of plaque instability (plaque volume > 70%, minimum lumi
Sponsor: S.M. Misericordia Hospital

Current Primary Outcome: Percentage of coronary plaques with LCBImax > 400 in lesions with FFR > 0.80 vs lesions with FFR < 0.80. [ Time Frame: Baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: S.M. Misericordia Hospital

Dates:
Date Received: December 5, 2016
Date Started: March 2015
Date Completion: December 2018
Last Updated: December 9, 2016
Last Verified: December 2016