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R01HL157712

Project Grant

Overview

Grant Description
Dual-Modality FLIM and PSOCT for Intravascular Imaging of Plaque in Patients - Project Summary/Abstract

The clinical management of coronary artery disease (CAD) and the prevention of acute coronary syndromes (ACS) require knowledge of the underlying atherosclerotic plaque pathobiology. Current intravascular standalone imaging techniques are limited in their ability to evaluate processes that lead to plaque progression and sudden changes in plaque structure (e.g. rupture or erosion) conducive to ACS in humans. Hybrid intravascular imaging systems hold premises for a more comprehensive evaluation of plaque pathobiology in patients and are urgently needed.

Our goal is to address this need through the development of an intravascular imaging approach capable of simultaneous assessment of changes in plaque biochemical composition and morphology associated with critical pathobiological processes in patients. We propose to advance an intravascular imaging system combining two complementary label-free optical techniques, specifically, fluorescence lifetime imaging (FLIM) and polarization sensitive optical coherent tomography (PSOCT) via an innovative bimodal imaging catheter suitable for percutaneous coronary imaging (PCI).

This dual-modality approach should 1) yield great insight into the interplay of biochemical-morphological features that have a key role in plaque progression, destabilization, and/or remodeling and 2) enable immediate display of this information in near real-time, in a visual format useful for guiding personalized management of coronary lesions at the time of cardiac catheterization.

The proposed technique will be able to perform safe and rapid co-registered measurement of (1) time-resolved fluorescence decays in multiple spectral emission bands, and (2) polarization-resolved optical tomographic data in a single pullback.

To achieve our goal, we will first construct a FLIM-PSOCT catheter system including a freeform reflective optic providing optimized optical performance for both FLIM and PSOCT (Aim 1). Second, to demonstrate FLIM-PSOCT's performance for fast and simultaneous/synergistic assessment of critical biochemical features associated with distinct morphological features, we will use the proposed hybrid system to image human coronary samples (ex vivo), with histopathology corroboration (Aim 2). Finally, we will deploy this system in patients (first-in-human) to evaluate plaques during cardiac catheterization and determine clinical feasibility (Aim 3).

The successful completion of this study will demonstrate the clinical feasibility and utility of intracoronary FLIM-PSOCT for assessment of critical plaque features likely to cause ACS. If such features can be reliably detected, the patients undergoing PCI procedures may benefit from personalized treatment of these plaques and improved outcome.
Funding Goals
TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.
Place of Performance
Davis, California 95618 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 414% from $667,507 to $3,431,403.
Davis University Of California was awarded Intravascular Dual-Modality Imaging Plaque Pathobiology in Patients Project Grant R01HL157712 worth $3,431,403 from National Heart Lung and Blood Institute in September 2021 with work to be completed primarily in Davis California United States. The grant has a duration of 5 years and was awarded through assistance program 93.837 Cardiovascular Diseases Research. The Project Grant was awarded through grant opportunity NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed).

Status
(Ongoing)

Last Modified 9/5/25

Period of Performance
9/10/21
Start Date
8/31/26
End Date
80.0% Complete

Funding Split
$3.4M
Federal Obligation
$0.0
Non-Federal Obligation
$3.4M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01HL157712

Subgrant Awards

Disclosed subgrants for R01HL157712

Transaction History

Modifications to R01HL157712

Additional Detail

Award ID FAIN
R01HL157712
SAI Number
R01HL157712-1855895626
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Funding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Awardee UEI
TX2DAGQPENZ5
Awardee CAGE
1CBG4
Performance District
CA-04
Senators
Dianne Feinstein
Alejandro Padilla

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Heart, Lung, and Blood Institute, National Institutes of Health, Health and Human Services (075-0872) Health research and training Grants, subsidies, and contributions (41.0) $1,394,798 100%
Modified: 9/5/25