Lipid-riche Plaque study, version 1.10
Research type
Research Study
Full title
Lipid-rich Plaque (LRP) study
IRAS ID
159534
Contact name
Priti Shah
Contact email
Sponsor organisation
Infraredx
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 17 days
Research summary
Currently, millions of individuals throughout the world suffer from heart attacks and in some cases sudden cardiac death. Both conditions result from sudden lack of adequate blood flow to the heart muscle caused by a blockage within the coronary arteries. The most common cause of a rapid increase in blockage, and heart attack, is the formation of a clot over a ruptured plaque. It is generally believed that plaques most likely to rupture are rich in cholesterol and other fats. Such fatty plaques are considered to be high-risk, or vulnerable to rupture. Plaques that are made of fibrous tissue are considered to be less likely to rupture.
InfraReDx, Inc. has developed a device that has been cleared by the FDA to identify fatty plaques in the coronary artery. The measurement requires that a tube (catheter) be inserted into the artery in the leg or arm and advanced into the coronary artery.
The device used in this study is called the TVC Imaging System, and was approved by the FDA on June 30, 2010. An infrared laser light is used to determine if the plaque is fatty (potentially dangerous) or made of stable fibrous material; the device also utilizes ultrasound to obtain a picture of the plaque.
The study will only be conducted in patients in whom the treating physician plans to utilize the ultrasound feature of the catheter as part of the routine care of the artery that has already been causing a difficulty. In that artery (or arteries) the infrared light may provide additional useful information by informing the physician if the plaque is likely to cause complications during stenting.
Permission for research is requested for use of the TVC system in a second or third coronary artery. Under regular care, the TVC system would not be used in these additional arteries, which do not have blockages. The purpose of using TVC in these additional arteries is to identify fatty plaques that might cause future difficulties.
If at least 1 large fatty plaque was found in a part of the artery that was not treated, patients will be contacted by telephone at 2, 6, 12, 24 months for follow up. If no large fatty plaque was found patients have 50% chance to be assigned to a group that will receive the same phone call follow-up as those with the fatty plaques. For the other 50% of patients the participation in this study will end upon discharge from the hospital after your procedure.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1744
Date of REC Opinion
23 Dec 2014
REC opinion
Further Information Favourable Opinion