Trial DesignThe Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale
Section snippets
Cross-sectional observations of NIRS-IVUS imaging
NIRS has been rigorously validated against autopsy specimens and is the only technology to carry an FDA label claim for the detection of lipid core.15., 16. Studies of the combined NIRS-IVUS system have consistently demonstrated its utility as compared to IVUS alone or NIRS alone.17
NIRS-IVUS imaging in patients who have already experienced a coronary event has detected a high incidence of lipid and large plaque burden at culprit lesion sites.18., 19. Madder et al. demonstrated that large
Prospective utility of NIRS-IVUS imaging
In aggregate, there are multiple lines of evidence suggesting that NIRS-IVUS imaging has the potential to provide a measure of vulnerable coronary plaque that is of value for more precise categorization of coronary patients. Given this array of promising NIRS-IVUS data, the decision was made in 2014 to launch the prospective, multicenter Lipid-Rich Plaque (LRP) outcomes study (NCT02033694). The study was designed to test the hypotheses in a cohort of over 1,500 patients undergoing cardiac
Design of the LRP study
The aim of the LRP study is to evaluate the correlation between the presence of non-flow-limiting, non-intervened lipid-rich plaques detected by NIRS-IVUS imaging in two or more coronary arteries and the development of a major adverse cardiac event (MACE) caused by a de novo culprit lesion within the 24 months post-imaging. Inclusion criteria are listed in Table I. MACE is defined as the composite incidence of cardiac death, cardiac arrest, myocardial infarction, revascularization, acute
Summary
The LRP study will test the hypotheses that NIRS-IVUS imaging to detect LRP in patients who have undergone a cardiac catheterization can identify vulnerable patients and vulnerable plaques. Identification of vulnerable patients will assist future studies of novel systemic therapies; identification of vulnerable plaques will lead to studies that can evaluate local plus systemic treatment of the plaques likely to cause future events.
References (24)
- et al.
The myth of the "vulnerable plaque": transitioning from a focus on individual lesions to atherosclerotic disease burden for coronary artery disease risk assessment
J Am Coll Cardiol
(2015) - et al.
The Search for Vulnerable Plaque — The Pace Quickens
J Invasive Cardiol
(2013) - et al.
Pathologic assessment of the vulnerable human coronary plaque
Heart
(2004) Inflammation in atherosclerosis
Nature
(2002)- et al.
In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study
JACC Cardiovasc Imaging
(2009) - et al.
Combined IVUS and NIRS detection of fibroatheromas: histopathological validation in human coronary arteries
JACC Cardiovasc Imaging
(2015) - et al.
Composition of target lesions by near-infrared spectroscopy in patients with acute coronary syndrome versus stable angina
Circ Cardiovasc Interv
(2012) - et al.
Confirmation of the Intracoronary Near-Infrared Spectroscopy Threshold of Lipid-Rich Plaques That Underlie ST-Segment-Elevation Myocardial Infarction
Arterioscler Thromb Vasc Biol
(2016) - et al.
Large lipid-rich coronary plaques detected by near-infrared spectroscopy at non-stented sites in the target artery identify patients likely to experience future major adverse cardiovascular events
Eur Heart J Cardiovasc Imaging
(2016) WHO | Global status report on noncommunicable diseases 2014 [Internet]
Effects of statins in reducing thrombotic risk and modulating plaque vulnerability
Clin Cardiol
A prospective natural-history study of coronary atherosclerosis
N Engl J Med
First-in-man clinical use of combined near-infrared spectroscopy and intravascular ultrasound: a potential key to predict distal embolization and no-reflow?
J Am Coll Cardiol
Cited by (0)
RCT# NCT02033694
Relationship with industry:
Ron Waksman, MD, Consultant: Abbott Vascular, Biotronik, Boston Scientific, Medtronic, St. Jude Medical; Speakers Bureau: AstraZeneca, Boston Scientific, Merck; Grant Support: Infraredx, AstraZeneca, Biotronik, and Boston Scientific
Sean Madden, PhD, Employee, Infraredx, Inc.
Priti Shah, MS, Employee, Infraredx, Inc.
James Muller, MD, Consultant, Infraredx, Inc.
Clinical Trial Registration: Clinicaltrials.gov Identifier: NCT02033694.