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 |
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.
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
171 Ashley Avenue
Charleston, South Carolina 29425
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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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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110 Irving St NW
Washington, District of Columbia 20010
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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