The Lipid-Rich Plaque Study



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/20/2018
Start Date:February 2014
End Date:October 2018

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The Lipid-Rich Plaque (LRP) Study

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.


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:

1. Subjects presenting with an acute coronary syndrome (ACS) including at least one
of the following:

1. Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits
of normal;

2. ST depression or ST elevation >1mm in 2 or more contiguous leads in the
absence of LVH, paced rhythm, BBB or early repolarization;

3. 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

- 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.
We found this trial at
32
sites
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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Atlanta, Georgia 30306
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Atlanta, GA
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Atlantis, Florida 33462
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Atlantis, FL
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Bay City, Michigan 48708
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Bay City, MI
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, West Virginia 25304
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Cleveland, Ohio 44109
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Cleveland, OH
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Delray Beach, Florida 33431
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Detroit, Michigan 48210
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Elk Grove Village, Illinois 60007
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Elk Grove Village, IL
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Hialeah, Florida
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46250
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Indianapolis, IN
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Layton, UT
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Los Angeles, CA
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Merrillville, Indiana
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Minneapolis, Minnesota 55455
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Mount Clemens, Michigan 48043
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New York, New York
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New York, New York 10021
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Orlando, Florida 32803
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Palm Beach Gardens, Florida 33410
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Pembroke Pines, Florida 33028
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Plano, Texas
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Rochester, Michigan 48307
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Rochester, MI
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Rome,
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Springfield, Illinois
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Tulsa, OK
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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