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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With 2 Years Follow up | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS-IVUS Imaging (TVC Imaging System) | Device | Diagnostic Imaging Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 | 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:
|
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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:
Unstable angina pectoris;
Stable angina pectoris and/or a positive functional study with evidence of ischemia.
Angiographic Inclusion Criteria
IVUS/NIRS Imaging Inclusion Criterion
Exclusion Criteria:
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Patients presenting for coronary angiography in whom IVUS and/or NIRS evaluation is planned or could be utilized as part of their clinically-indicated evaluation will be screened for participation.
All enrolled patients with a large LRP (Maximum Lipid Core Burden Index>250 in 4 mm or maxLCBI4mm>=250) was contacted by phone for each clinical follow up visit to determine if a new coronary event had occurred. A randomly selected half of the patients with a small, or no LRP (MaxLCBI4mm<250) received an identical follow-up. The remaining half of the small or no LRP group did not have follow up visits and therefore were not included in the primary analysis. The determination of the need for follow-up was made by a core lab and communicated to the clinical site.
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| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | MedStar Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles Medical Center | Los Angeles | California | United States | |||
| Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28938968 | Background | Waksman R, Torguson R, Spad MA, Garcia-Garcia H, Ware J, Wang R, Madden S, Shah P, Muller J. The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017 Oct;192:98-104. doi: 10.1016/j.ahj.2017.02.010. Epub 2017 Feb 16. | |
| 31570255 | Background | Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27. |
| Label | URL |
|---|---|
| The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017 | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With 2 Year Follow up | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2013 |
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| 2 years |
| Washington D.C. |
| District of Columbia |
| United States |
| JFK Medical Center | Atlantis | Florida | United States |
| Delray Medical Center | Delray Beach | Florida | United States |
| Palmetto General Hospital | Hialeah | Florida | United States |
| Florida Hospital Orlando | Orlando | Florida | United States |
| Palm Beach Gardens Medical Center | Palm Beach Gardens | Florida | United States |
| Memorial Hospital West | Pembroke Pines | Florida | United States |
| Emory Midtwon | Atlanta | Georgia | United States |
| Emory University | Atlanta | Georgia | United States |
| Alexian Brothers Heart and Vascular Institute | Elk Grove Village | Illinois | United States |
| St. John's Springfield | Springfield | Illinois | United States |
| Community Heart & Vascular | Indianapolis | Indiana | United States |
| Methodist | Merrillville | Indiana | United States |
| Central Baptist Hospital | Lexington | Kentucky | United States |
| McLaren Bay Region | Bay City | Michigan | United States |
| St. John's | Detroit | Michigan | United States |
| McLaren-Macomb | Mount Clemens | Michigan | United States |
| Crittenton Hospital | Rochester | Michigan | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | United States |
| Columbia University | New York | New York | United States |
| LIJ Health System | New York | New York | United States |
| New York Presbyterian Hospital Cornell | New York | New York | United States |
| Metrohealth | Cleveland | Ohio | United States |
| Hillcrest Oklahoma Heart Institute | Tulsa | Oklahoma | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| University of Texas Medical Branch | Galveston | Texas | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | United States |
| Heart Hospital Plano | Plano | Texas | United States |
| Davis Hospital and Medical Center | Layton | Utah | United States |
| Charleston Area Medical Center | Charleston | West Virginia | United States |
| San Biovanni Hospital | Rome | Italy |
| Latvian Centre of Cardiology | Riga | Latvia |
| Academic Medical Center | Amsterdam | Netherlands |
| Radboud University Medical Centre | Nijmegen | Netherlands |
| Erasmus Medical Centre | Rotterdam | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | Netherlands |
| SUSCCH, a.s. | Banská Bystrica | Slovakia |
| Golden Jubilee National Hospital | Clydebank | United Kingdom |
| University of Edinburgh | Edinburgh | United Kingdom |
| Royal Brompton Hospital | London | United Kingdom |
| 37271594 | Derived | Torguson R, Mintz GS, Di Mario C, Ten Cate T, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Kuku KO, Garcia-Garcia HM, Waksman R. Disparities among Black and White patients in plaque burden and composition and long-term impact. Cardiovasc Revasc Med. 2023 Oct;55:28-32. doi: 10.1016/j.carrev.2023.04.023. Epub 2023 May 1. |
| 36058829 | Derived | Case BC, Torguson R, Mintz GS, Di Mario C, Medranda GA, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Additive Effect of Multiple High-Risk Coronary Artery Segments on Patient Outcomes: LRP Study Sub-Analysis. Cardiovasc Revasc Med. 2023 Jan;46:38-43. doi: 10.1016/j.carrev.2022.08.008. Epub 2022 Aug 6. |
| 35842005 | Derived | Torguson R, Mintz GS, Case BC, Di Mario C, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Correlation between lipidic content and arterial-wall plaque burden: A Lipid Rich Plaque study sub-analysis. Int J Cardiol. 2022 Nov 1;366:32-34. doi: 10.1016/j.ijcard.2022.07.024. Epub 2022 Jul 13. |
| 34972665 | Derived | Case BC, Shea C, Torguson R, Zhang C, Yerasi C, Medranda GA, Kuku KO, Garcia-Garcia HM, Mintz GS, Waksman R. Impact of Baseline Imaging of Non-Culprit Coronary Lesions on Adverse Events: Insight From LRP Study. Cardiovasc Revasc Med. 2022 Jun;39:1-5. doi: 10.1016/j.carrev.2021.12.012. Epub 2021 Dec 13. |
| 34465457 | Derived | Torguson R, Shlofmitz E, Mintz GS, Mario CD, Cate TT, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Frequency of Lipid-Rich Coronary Plaques in Stable Angina Pectoris versus Acute Coronary Syndrome (from the Lipid Rich Plaque Study). Am J Cardiol. 2021 Nov 1;158:1-5. doi: 10.1016/j.amjcard.2021.07.033. Epub 2021 Aug 28. |
| 34455112 | Derived | Bambagioni G, Di Mario C, Torguson R, Demola P, Ali Z, Singh V, Skinner W, Artis A, Cate TT, Zhang C, Garcia-Garcia HM, Doros G, Mintz GS, Waksman R. Lipid-rich plaques detected by near-infrared spectroscopy predict coronary events irrespective of age: A Lipid Rich Plaque sub-study. Atherosclerosis. 2021 Oct;334:17-22. doi: 10.1016/j.atherosclerosis.2021.08.022. Epub 2021 Aug 14. |
| Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With 2 Year Follow up | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Participant could identify as more than one race/ethnicity and may be counted in more than one race/ethnicity category | Count of Participants | Participants |
| ||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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:
| 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). | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 | 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:
| 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) | Posted | Count of Participants | Participants | 2 years |
|
|
2 years
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients With Baseline NIRS-IVUS Imaging | Participants with NIRS-IVUS imaging at baseline | 0 | 1,563 | 6 | 1,563 | 0 | 1,563 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissection | Cardiac disorders | Systematic Assessment | Intraprocedural complication |
| |
| Bradycardia | Cardiac disorders | Systematic Assessment | Intraprocedural complication |
| |
| Thrombus with Chest Pain | Cardiac disorders | Systematic Assessment | Intraprocedural complication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priti Shah | Infraredx, A Nipro Company | 781-345-9646 | 646 | pshah@infraredx.com |
| Apr 13, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Asian Pacific |
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| Native American |
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| Other |
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| Hispanic |
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| United States |
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| United Kingdom |
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| Italy |
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| Slovakia |
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| 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. | Regression, Cox | <0.0001 | Cox Proportional Hazard | 1.45 | 2-Sided | 95 | 1.30 | 1.60 | Other |
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