Lipid-Rich Plaque in the coronary arteries
Conditions
Interventions
None listed
Sponsors
Infraredx
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria 1. Subjects presenting for coronary angiography in whom IVUS imaging is likely to be performed for clinical purposes. 2. Greater than 18 years of age. 3. Clinical presenting symptoms meeting one of the three criteria below: 1. Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following: a) Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal; b) ST depression or ST elevation >1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization; c) A stabilized patient 24 to 72 hours post STEMI; 2. Unstable angina pectoris; 3. Stable angina pectoris and/or a positive functional study with evidence of ischemia.;Angiographic Inclusion Criteria 4. At least one Suspected Index Culprit Lesion requiring imaging with IVUS and/or NIRS for clinical indications. 5. At least two native epicardial coronary arteries (which may include the Suspected Index Culprit Artery) eligible for imaging with NIRS-IVUS. ;Total IVUS/NIRS Imaging Inclusion Criterion 6. A minimum of a total 50 mm of coronary artery not involved in a prior or Index Procedure PCI (including the 5mm borders on either edge of the site receiving PCI) must be scanned. This 50mm total length may include contributions from the Suspected Index Culprit Arteries and from Index Non-Culprit Arteries. This total length must include contributions from two or more native imaged arteries.
Exclusion criteria
Exclusion criteria: 1. Unstable patients (STEMI within the prior 24 hours; cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, and IABP) and patients that had a procedural complication (coronary dissection, perforation or a complication that would necessitate immediate-unplanned revascularization) during index PCI procedure. 2. History of CABG or planned CABG within 6 months following NIRS-IVUS imaging. 3. Patient has additional lesion(s) that needs a staged PCI. 4. Subject life expectancy is less than 2 years at time of index catheterization. 5. Subject with ejection fraction (EF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the Test of the Vulnerable Patient Hypothesis The primary baseline measurement will be the maximum LCBI in 4 mm (max 4mm LCBI) over all scanned portions of the coronary arteries. The portion of artery to be scanned will exclude sites in which PCI has been performed in the past or will be performed in the index procedure (also excluding 5 mm borders of any site that underwent PCI). The primary endpoint for the test of the vulnerable patient hypothesis will be the incidence of NC-MACE within 24 months For the Test of the Vulnerable Plaque Hypothesis The primary baseline measurement will be the maximum 4 mm LCBI detected in each proximal, mid, or distal segment of coronary artery scanned. The portion of artery to be scanned will exclude sites in which PCI has been performed in the past or will be performed in the index procedure (including 5 mm borders of any site that underwent PCI). The primary endpoint for the test of the vulnerable plaque hypothesis will be the incidence of NC-MACE within 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The LRP Outcomes Study will produce a large amount of novel information that creates the opportunity for analysis of multiple secondary endpoints, multiple tertiary endpoints and multiple subgroups. Various methods of analysis and definitions of exposure, response and outcomes in subgroups of interest will be examined. Examples of each category and their relation to the primary endpoint are given below. | — |
Countries
Netherlands
Outcome results
None listed