Saint Luke's Imaging Core Laboratory

History and overview

The Imaging Core Laboratory at Saint Luke’s Mid America Heart Institute has participated in numerous clinical trials and registries since 2004, providing independent, accurate analysis of cardiovascular imaging.

Our experts have analyzed thousands of patient cases and image records using multiple technologies in investigative pharmacologic and therapeutic device evaluation studies. We have also studied and devised adjunctive methods to improve the accuracy of commercially available imaging systems.

Under the medical direction of David Safley, MD, and Michael Main, MD, we are actively engaged in numerous clinical trials in the cardiovascular device and drug development sectors. Our services assist organizations seeking to evaluate therapies using established and novel imaging modalities, including contrast angiography intravascular ultrasound (IVUS) with virtual histology (VH Philips Healthcare, San Diego, California) and iMAP (Boston Scientific, Natick, Massachusetts) analysis, optical coherence tomography (OCT), and echocardiography.

We guarantee independent and accurate centralized analysis, according to current industry standards and definitions. A description of our imaging capabilities and related analytical services follows.

Services offered

• Study start-up
• Centralized collection, management, and storage of subject image data
• Quality assurance
• Expert independent blinded image review
• Image analysis of angiography, VH-IVUS, OCT, and echocardiography
• Statistical analysis
• Reporting of results

Our standard operating procedures comply with the latest industry and regulatory guidelines, including 21 CFR Part 11 and ICH E6 Good Clinical Practice. Internal and external validation studies have been performed to ensure accurate, replicable results and reporting.

Imaging modalities 

Saint Luke’s Imaging Core Laboratory utilizes the latest in intravascular analytic software as well as echocardiographic imaging tools to ensure standardized measurements and results. 

Intravascular ultrasound (IVUS) 

IVUS is a catheter-based tool widely used to assess atherosclerotic disease and vascular anatomy. The Imaging Core Laboratory utilizes Indec echoPlaque 4.0 software (Los Altos, California) for the evaluation of coronary and peripheral arteries as well as venous structures. Our software is able to analyze IVUS images captured from all commercially available IVUS systems (Volcano, Boston Scientific, Acist). We can generate a wide variety of reportable measurements such as vessel and lumen size, stent apposition, and presence of thrombus. 

Key IVUS results

• Lumen area and diameter measurements
• Vessel area and diameter measurements 
• Tissue classification 
• Plaque volume
• Neo-intimal plaque volume
• Stent apposition 

Optical coherence tomography (OCT)

OCT is a light-based imaging modality providing intravascular resolution at 15 microns. The near field resolution provides accurate assessment of stent apposition, stent tissue coverage, and thrombus. OCT allows for detailed assessment of tissue morphologies and classification of stable atherosclerosis as well as acute coronary syndromes. 

Key OCT results

• Lumen area and diameter measurements
• Vessel area and diameter measurements
• Plaque volume
• Neo-intimal plaque volume
• Stent apposition 

Angiography

Quantitative angiographic data is obtained through quantitative coronary angiography (QCA) and quantitative vascular angiography (QVA). QCA and QVA provide objective and reproducible measurements of coronary artery and peripheral vascular dimensions.

Each are particularly useful for assessing the vessel lumen size, restenosis after percutaneous interventions, evaluation of mechanical interventional devices (e.g. stents and balloon therapy), and the long-term progression and regression of atherosclerosis. Saint Luke’s Imaging Core Laboratory utilizes the industry’s latest QAngio software from Medis (Leiden, The Netherlands). 

Key angiographic results

• Minimum luminal diameter
• Reference diameter
• Percentage diameter stenosis
• Stenotic length 
• Bifurcation angles

Quality assurance program 

To ensure accuracy and reliability, we follow a Standard Operating Procedure (SOP)-driven quality assurance program for each modality in use. The core lab undergoes regular internal validation studies complete with biostatistical review. All imaging readers have documented excellent reliability as determined by the staff independent blinded biostatistician. 

Selected studies

Saint Luke’s Imaging Core Laboratory has participated in numerous pharmacologic and therapeutic device trials and registries. Our researchers and technicians have also studied and devised adjunctive methods to improve the accuracy of commercially available imaging systems.

Cardiac allograft vasculopathy (CAV) following orthotopic heart transplant (OHT)

Angiography and radiofrequency IVUS are prospectively performed four and 52 weeks after patients undergo post-OHT at Saint Luke’s Mid America Heart Institute. To date, more than 400 patients have been evaluated.

VIRTUS: Trial

This is a multi-center, prospective, single arm, non-randomized study to evaluate the safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined objective performance goals.

OPEN-CTO Registry

This is an observational registry of 1,000 participants. The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study.

ASAP-TOO

The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN™ device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anticoagulation therapy to reduce the risk of stroke.

SALUTE

A study to evaluate the safety and effectiveness of left atrial appendage closure therapy using BSJ003W for patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese medical environment.

PRESERVED-HF Trial - Echocardiography substudy

Investigator-initiated trial to study the effects of dapagliflozin vs. placebo on various echocardiographic parameters.

VH-IVUS pilot study and software development

We were one of the first U.S. sites to pilot test the VH-IVUS technology and collaborate with software developers at Volcano Corp., to improve its experimental and commercially available software applications.

Global VH Prospective Registry

A multi-center registry of approximately 2,500 patients undergoing diagnostic catheterization and/or PCI with VH-IVUS. Our technicians analyzed the last 300 images from the registry.                   

Diabetes Genome Project—IVUS substudy

A prospective registry consisting of 1,600 patients enrolled at two centers. A subgroup of patients (n=200) underwent PCI with VH-IVUS.

Axial measurement errors of IVUS catheters

These experiments quantified errors associated with axial measurement of IVUS catheters in phantom models.

BLAST trial

A prospective, global, multi-center randomized study of patients undergoing PCI for a bifurcation lesion using drug-eluting stents. The primary objective is to demonstrate that IVUS with VH guidance leads to better post procedural outcomes when compared to angiographic guidance alone. Nearly 200 patients were enrolled.

Contact us

To learn more about Saint Luke’s Imaging Core Laboratory, please contact us at corelab@saintlukeskc.org or 816-432-3524.