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The Lipid-Rich Plaque Study (LRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033694
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
InfraReDx

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Conditions Coronary Artery Disease
Atherosclerosis
Intervention Device: NIRS-IVUS Imaging (TVC Imaging System)
Enrollment 1563
Recruitment Details Enrolled patients with a large LRP (Maximum Lipid Core Burden Index>250 in 4 mm or maxLCBI4mm>=250) were assigned to 2 year follow up to determine if a new coronary event had occurred. A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm<250) had 2 year follow up.
Pre-assignment Details A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm<250) did not have 2 year follow up and were not included in the primary analyses. This reduced the total number of patients followed for two years to 1271 patients.
Arm/Group Title Participants With 2 Year Follow up
Hide Arm/Group Description Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Period Title: Overall Study
Started 1271
Completed 1271
Not Completed 0
Arm/Group Title Participants With 2 Year Follow up
Hide Arm/Group Description Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Overall Number of Baseline Participants 1271
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1271 participants
64  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1271 participants
Female
388
  30.5%
Male
883
  69.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1271 participants
Caucasian
942
  74.1%
African American
158
  12.4%
Asian Pacific
44
   3.5%
Native American
0
   0.0%
Other
128
  10.1%
Hispanic
101
   7.9%
[1]
Measure Description: Participant could identify as more than one race/ethnicity and may be counted in more than one race/ethnicity category
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1271 participants
Netherlands
187
  14.7%
Latvia
10
   0.8%
United States
1001
  78.8%
United Kingdom
46
   3.6%
Italy
10
   0.8%
Slovakia
17
   1.3%
1.Primary Outcome
Title 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
Hide Description

Association of maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) as a continuous value in 100 unit increments in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level

Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of:

  • cardiac death
  • cardiac arrest
  • non-fatal myocardial infarction (MI)
  • acute coronary syndrome
  • revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI)
  • rehospitalization for progressive angina, related to a non-index culprit lesion
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients assigned to 2 year follow up were analyzed, at the patient and plaque level, to test the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE).
Arm/Group Title Participants With 2 Year Follow up
Hide Arm/Group Description:
Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Overall Number of Participants Analyzed 1271
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with NC-MACE
104
   8.2%
Participants with No NC-MACE
1167
  91.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With 2 Year Follow up
Comments Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
1.09 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With 2 Year Follow up
Comments Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.30 to 1.60
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400
Hide Description

Association of maxLCBI4mm more than and less than a threshold of 400 in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level

Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of:

  • cardiac death
  • cardiac arrest
  • non-fatal myocardial infarction (MI)
  • acute coronary syndrome
  • revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI)
  • rehospitalization for progressive angina, related to a non-index culprit lesion
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients assigned to 2 year follow up were analyzed, at the patient and plaque level to test the association between maximum 4mm Lipid Core Burden index (maxLCBI4mm) >400 and Non-Index Culprit Lesion related Major Cardiac Events (NC-MACE)
Arm/Group Title Participants With 2 Year Follow up
Hide Arm/Group Description:
Participants with NIRS-IVUS imaging at baseline and follow up for 2 years
Overall Number of Participants Analyzed 1271
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with NC-MACE
104
   8.2%
Participants with No NC-MACE
1167
  91.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With 2 Year Follow up
Comments Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm > 400 as the independent variable and NC-MACE during 2 years as the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
1.48 to 3.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With 2 Year Follow up
Comments Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm > 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 4.22
Confidence Interval (2-Sided) 95%
2.39 to 7.45
Estimation Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description The device has been approved as safe for imaging of coronary arteries by the FDA. Experience in greater than 5,000 patients has shown that the device safety profile does not differ from that of a conventional IVUS catheter. Serious adverse events associated with the device in the additional, non-culprit vessels were collected because this was the additional requirement for the study outside of routine medical care.
 
Arm/Group Title All Patients With Baseline NIRS-IVUS Imaging
Hide Arm/Group Description Participants with NIRS-IVUS imaging at baseline
All-Cause Mortality
All Patients With Baseline NIRS-IVUS Imaging
Affected / at Risk (%)
Total   0/1563 (0.00%)    
Hide Serious Adverse Events
All Patients With Baseline NIRS-IVUS Imaging
Affected / at Risk (%) # Events
Total   6/1563 (0.38%)    
Cardiac disorders   
Dissection  [1]  4/1563 (0.26%)  4
Bradycardia  [1]  1/1563 (0.06%)  1
Thrombus with Chest Pain  [1]  1/1563 (0.06%)  1
Indicates events were collected by systematic assessment
[1]
Intraprocedural complication
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients With Baseline NIRS-IVUS Imaging
Affected / at Risk (%) # Events
Total   0/1563 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Priti Shah
Organization: Infraredx, A Nipro Company
Phone: 781-345-9646 ext 646
EMail: pshah@infraredx.com
Layout table for additonal information
Responsible Party: InfraReDx
ClinicalTrials.gov Identifier: NCT02033694    
Other Study ID Numbers: The LRP Study
First Submitted: January 8, 2014
First Posted: January 13, 2014
Results First Submitted: April 13, 2020
Results First Posted: May 19, 2020
Last Update Posted: May 19, 2020