Feature | November 06, 2013

MedStar Heart Institute, Infraredx Initiate Lipid Rich Plaque Study to Evaluate Prediction of Heart Attacks

Positive results with the Infraredx Near-Infrared Spectroscopy (NIRS) TVC coronary imaging system led to the decision to launch 9,000-patient trial

Infraredx TVC Imaging System, Infraredx, TVC Imaging System

Infraredx TVC Imaging System

November 6, 2013MedStar Heart Institute of Washington, D.C. and Infraredx, Inc. announced the initiation of the Lipid-Rich Plaque (LRP) Study, a prospective, multi-center study designed to evaluate the ability of intravascular imaging to identify patients with LRPs who are at a higher risk for heart attacks and other serious coronary events. LRPs are a type of fatty coronary artery plaque implicated in most heart attacks, and will be identified using the Infraredx TVC Imaging System, a first-in-class catheter-based intravascular imaging technology. The study, which will be sponsored by Infraredx, seeks to enroll 9,000 patients, and will examine the correlation between the presence of LRPs and the occurrence of a cardiac event during the 24 months after imaging. MedStar Heart Institute is one of 100 clinical sites across the country to participate in the trial.

The TVC system integrates near-infrared spectroscopy (NIRS) lipid core plaque detection technology, and enhanced intravascular ultrasound (IVUS) imaging to visualize the presence of plaques, quantify the degree of vessel stenosis (narrowing) and identify plaques suspected to be prone to rupturing and causing dangerous blockages. Current methods of diagnosing coronary artery disease are limited in their ability to detect such plaques.

A recent study [1] published in the Journal of the American College of Cardiology Cardiovascular Interventions, demonstrated that NIRS imaging detected a distinct signature of a cholesterol plaque at the sites causing major heart attacks. A second study [2] found that increased cholesterol (detected by NIRS imaging) in a non-culprit artery indicated the patient had a four-fold multivariate increase in risk of a coronary event over the subsequent year.

“This innovative and uniquely designed study will finally answer the decades-old question of whether or not we can accurately identify a vulnerable plaque” said Ron Waksman, M.D., director, cardiovascular research and advanced education with MedStar Heart Institute, and the international principal investigator of the LRP study. “The LRP study will utilize the TVC system to identify lipid rich plaques in patients undergoing stenting. We will then follow the patients for two years to determine if these suspected vulnerable plaques cause coronary events.”

“Successful prediction in the study will permit us to identify patients and lesions at increased risk,” said Waksman. “We can then utilize treatment modalities, drug or device, or a combination, to help mitigate this risk.”

The study will be conducted in approximately 100 hospitals located throughout the world. Dr. Carlo Di Mario of London, England will serve as Principal investigator for Europe. Dr. Takeshi Akasaka of Wakayama, Japan will serve as Principal Investigator for Japan, a country with advanced coronary imaging experience. Dr. Yasunori Ueda of Osaka, Japan will serve as co-principal investigator for Japan.

The LRP study will start enrollment in December 2013 and conclude follow-up for the last patient in December 2017. The study will initially focus on validating the ability of NIRS-IVUS imaging to predict coronary events. If and when that goal is achieved, the study will transition to a blinded, randomized study of TVC-guided preventive treatment.

For more information: www.infraredx.com

References:

1. Madder et al, JACC Interventions 2013

2. Oemrawsingh et al, European Heart Journal, in press 2013

Related Content

cardiac surgery, simulation training, University of Washington, case studies

Multiple repetitions of bypass grafts on a heart, using the Ramphal simulator. Courtesy of the University of Washington in Seattle.

News | Cardiovascular Surgery| August 25, 2016
August 25, 2016 — Simulation training fo
aortic dissection, family history, same age, clinical study, John A. Elefteriades, Annals of Thoracic Surgery
News | Structural Heart| August 25, 2016
People with a family member who had an aortic dissection — a spontaneous tear in one of the body’s main arteries —...
nanoparticles, blood clotting, internal bleeding, American Chemical Society study, Erin B. Lavik

Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. Image courtesy of Erin Lavik, Ph.D.

News | Hemostasis Management| August 24, 2016
August 24, 2016 — Whether severe trauma occurs on the battlefield or the highway, saving lives often comes down to...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
News | Heart Failure| August 23, 2016
August 23, 2016 — A new study of more than 13,000 people has found that so-called morbid obesity appears to stand alo
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
Overlay Init