The Lipid-Rich Plaque Study

Completed

Conditions studied: Coronary Artery Disease, Atherosclerosis

In brief

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.

Key facts

Study ID

NCT02033694

Run by

Infraredx

People needed

1563

Starts

2014-02-01

Expected to finish

2018-09-01

Last updated by the study team

2020-05-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University of California Los Angeles Medical Center — Los Angeles, California, United States
• Washington Hospital Center — 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

Full record on ClinicalTrials.gov

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