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

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Overlay Init