N/A
N=1,271
The Lipid-Rich Plaque Study
Coronary Artery Disease · Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02033694 ↗Enrolled (actual)
1,271
Serious AEs
0.4%
Results posted
May 2020
Primary outcome: Primary: Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable — 104; 1167 Participants — p=0.0004
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NIRS-IVUS Imaging (TVC Imaging System) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Infraredx
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable |
104; 1167 | 0.0004 sig |
| SECONDARY Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 |
104; 1167 | <0.0001 sig |
Summary
The purpose of this study is to enhance medical knowledge of the causes of future coronary problems. Many studies in patients who have already experienced a coronary problem point to the danger associated with plaques that are rich in cholesterol. This study determines if the near-infrared method of detection of these fatty plaques can predict future events. If dangerous plaques can be identified, there are many treatments already available that could be tested for their ability to prevent coronary events.
Eligibility Criteria
General Inclusion Criteria:
- Subjects presenting for coronary angiography in whom IVUS imaging is likely to be performed for clinical purposes.
- Greater than 18 years of age.
- Clinical presenting symptoms meeting one of the three criteria below:
- Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following:
- Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal;
- ST depression or ST elevation >1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization;
- A stabilized patient 24 to 72 hours post STEMI;
- Unstable angina pectoris;
- Stable angina pectoris and/or a positive functional study with evidence of ischemia.
Angiographic Inclusion Criteria
- At least one Suspected Index Culprit Lesion requiring imaging with IVUS and/or NIRS for clinical indications.
- At least two native epicardial coronary arteries (which may include the Suspected Index Culprit Artery) eligible for imaging with NIRS-IVUS.
IVUS/NIRS Imaging Inclusion Criterion
- 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
- 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.
- History of CABG or planned CABG within 6 months following NIRS-IVUS imaging.
- Patient has additional lesion(s) that needs a staged PCI.
- Subject life expectancy is less than 2 years at time of index catheterization.
- Subject with ejection fraction (EF) <30%.
- Subject pacemaker dependent/paced rhythm.
- Subject pregnant and lactating.
- Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
- Patients undergoing performance of PCI in all three major vessels during the index PCI.
Data sourced from ClinicalTrials.gov (NCT02033694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.