The ACERT™ Study is a partnership between The Society of Thoracic Surgeons (STS) and the American College of Cardiology Foundation (ACCF), with the ACCF acting as the lead organization. In this study, STS and ACCF are combining the power of the American College of Cardiology (ACC)’s clinical database for percutaneous coronary interventions (CathPCI) with the STS’s Adult Cardiac Surgery Database, which contains clinical information on coronary artery bypass graft (CABG) surgery, along with the Centers for Medicare and Medicaid Services (CMS) 100% denominator file data claims database to assess and compare outcomes for these two key methods of revascularization. The analytic center for clinical outcomes will be the Duke Clinical Research Institute (DCRI), and Christiana Care Center for Outcomes Research (CCOR) for economic outcomes. PERFUSE Angiographic Core Laboratories and Data Coordination Center will assess approximately 2,000 angiograms for the number of vessels diseased, SYNTAX score and PCI results. A steering committee comprised of representatives from the lead and consortium organizations will be responsible for the design, conduct, and reporting of the study.
American College of Cardiology Foundation
The mission of the American College of Cardiology (ACC) is to advocate for quality cardiovascular care— through education, research promotion, development and application of standards and guidelines—and to influence healthcare policy. NCDR® is the National Cardiovascular Data Registry, a confidential quality measurement program for cardiac and vascular facilities dedicated to improving the quality of cardiovascular patient care by providing information, knowledge, and tools; implementing quality initiatives; and supporting research that improves patient care and outcomes. Since the launching of the ACC-NCDR® CathPCI Registry in 1998, it has become the premier national, voluntary cardiovascular data registry that provides institutions with the ability to understand, measure, and improve quality of cardiovascular care. The NCDR® CathPCI Registry is composed of diagnostic cardiac catheterization and interventional procedures harvested from participating facilities across the United States. The registry was developed to respond to clinicians’ and hospitals’ needs for standardized elements to accurately describe clinical outcomes offering risk-adjusted quarterly data reports with comparisons against national and similar hospital benchmarks. The registry provides a comprehensive measurement system linked to clinical practice guidelines and to performance measures that rely on a set of nationally recognized standardized data elements and definitions.
Key performance measures are supplied to every NCDR® hospital each quarter, along with the explanation of the benchmarking methodology used, to facilitate comparison of one institution’s outcomes to results nationally. The NCDR® now has full data from more than 5 million cardiac catheterizations and more than 2.83 million PCI procedures performed at more than 1,000 U.S. hospitals. Efforts are underway at the NCDR® to develop longitudinal modules for the PCI registry. To promote and ensure data veracity and quality, internal quality checks of the data are assured by data quality reports on the submitted quarterly data, along with an external on-site auditing program.
In addition to providing one of the databases to be analyzed for this study, ACCF members serve as co-investigators for this study, including William Weintraub, MD, Principal Investigator. ACCF staff are responsible for study management and oversight, budget management, site recruitment and training, compliance management, risk management, project management, and overall study communications.
The Society of Thoracic Surgeons
The Society of Thoracic Surgeons (STS) is a not-for-profit organization representing cardiothoracic surgeons, researchers, and allied health professionals worldwide who are dedicated to ensuring the best surgical care for patients with diseases of the chest. Founded in 1964, the mission of STS is to enhance the ability of cardiothoracic surgeons to provide the highest quality care through education, research, and advocacy.
STS has always supported data-driven approaches to quality measurement, quality improvement, and quality reporting. The primary vehicle for the quality program has been the STS National Database, which was begun in 1989 and has now become the premier clinical data registry for cardiothoracic surgery. The more than 980 cardiac surgery centers participating in this registry constitute approximately 90% of cardiac surgery centers in the country. The STS Database contains more than 3.8 million surgical records, thereby making it the largest clinical cardiac surgery database in the world. The Database provides a comprehensive measurement system, which, through reporting to its participants, provides a series of quality performance measures, including structural, process, and risk-adjusted outcomes, that allow each participant to evaluate its performance against national referents.
Data included in the Database are collected in a standardized manner through the use of a common data collection form. Training and resources are provided to data entry and data management personnel to ensure consistency. Data are harvested on a quarterly basis and at the time of submission, each participant submitting a data file is provided with a report that indicates any data quality issues. Subsequent corrected data submission is permitted until the participant signs off on the data file. This process contributes to maximizing the accuracy and completeness of the data in the Database. Random external on-site audits of participating sites assess the accuracy, completeness, and comprehensiveness of the data in the Database.
The STS Database captures data on all adult patients undergoing cardiac surgical procedures performed by participants throughout the United States. The wealth of clinical information in the database has been the basis of well over 100 peer-reviewed publications and presentations at national and international meetings. The information collected over a 20-year period has been shown to improve patient outcomes, primarily through the feedback of reports allowing participants to compare local results against national risk-adjusted benchmarks.
In addition to providing one of the databases to be analyzed for this study, STS members serve as co-investigators for this study, including Fred Edwards, MD, Principal Investigator. In conjunction with ACCF staff, STS staff will provide study management and oversight, budget management, compliance management, risk management, project management, and overall study communications.
The ACCF and STS have worked collaboratively in the development of the datasets, and thus despite this project being sponsored by two different professional societies, the datasets have many common elements.
Duke Clinical Research Institute
The statistical coordinating center at the Duke Clinical Research Institute (DCRI) has participated in the development of standards and quality control for both the STS and the ACC NCDR® databases. In addition, given the years of experience working with these databases at DCRI, similar protocols have already been developed for handling missing data, data transformations, and model development; this experience will be leveraged in the current application.
The DCRI is the world’s largest academic clinical research organization, combining the clinical expertise and academic leadership of a premier teaching hospital with the full-service operational capabilities of a major contract research organization. With over 950 faculty and staff, DCRI is capable of conducting any clinical research project, from the smallest pilot study to truly global mega trials, medical device trials to outcomes and quality of life analyses. Their experience stretches from Phase I to Phase IV and beyond, encompassing post-approval analyses and health economics. DCRI provides every service needed for successful research, including project management, data management, site management and clinical monitoring, biostatistics, safety surveillance, and medical communications. DCRI’s full portfolio of abilities means their clients, who include pharmaceutical and medical device makers, biotech companies, and government agencies, can find a tailored research plan that meets their needs.
In line with DCRI’s mission of improving the practice of medicine, their faculty has a strong focus on disseminating research results, publishing more than 300 articles per year in peer-reviewed journals. The Institute’s effects on patient care and the state of medicine are felt around the world.
Christiana Care Center for Outcomes Research
The Christiana Care Center for Outcomes Research (CCOR) is a research center that has a dual focus on epidemiological research and analysis of outcomes, in all fields of medicine. In addition, it is a data coordinating center for a number of both large and small clinical trials in the area of cardiovascular diagnostics and therapeutics. The Center features:
- Specific expertise in the evaluation of quality of life, economic, and cost-effectiveness endpoints.
- Multidisciplinary approach to research with faculty including clinical researchers from the departments of Internal Medicine, Cardiology, Oncology, Traumatology of the Christiana Health Care Services, and researchers from the University of Delaware.
- Collaborations with investigators at other Institutions both nationally and internationally.
CCOR was established in 2005 to promote and conduct research aimed at improving patient care and to provide new evidence-based medical knowledge that could help shape healthcare policy. CCOR investigators whose shared expertise lies in cardiovascular diagnostics and therapeutics, evaluation of quality of life issues, economic impact and cost-effectiveness, are actively involved in their own studies as well as assisting others within the health system to pursue their own research areas of interest. These include clinical, epidemiologic, translational, and outcomes projects that are internal, industry-funded, or peer reviewed.
PERFUSE Angiographic Core Laboratories and Data Coordination Center
PERFUSE (Percutaneous/Pharmacologic Endoluminal Revascularization For Unstable Syndromes and its Evaluation) is an Angiographic Core Laboratory and Data Coordinating center that was established in 1988 by Dr. C. Michael Gibson. Since that time, PERFUSE has analyzed many tens of thousands of images from a wide range of international multicenter studies including interventional trials, thrombolytic trials, angiogenesis trials, atherosclerosis regression trials, peripheral interventional trials and animal laboratory studies. The PERFUSE Angiographic Core Laboratory provides accurate and precise data in a timely fashion, including quantitative coronary angiography (QCA) using FDA approved, and validated edge detection software.
The PERFUSE Data Coordinating Center enters and coordinates data from clinical trials. PERFUSE created the TIMI master database and served as the coordinating center for TIMI for nearly 15 years. Data is double-entered on site; all data are managed on site to streamline the entry and query processes. PERFUSE has over 20 years of experience as an angiographic core laboratory. The laboratory has demonstrated the ability to analyze films from international multicenter studies of over 3,000 patients and can analyze DICOM images from all vendors. The laboratory has served as the TIMI Angiographic Core Laboratory. The laboratory has analyzed films from interventional trials (e.g., TACTICS-TIMI 18, PROTECT-TIMI 32, TITAN), CABG trials (2,200 patient PREVENT 4 trial), and pharmacotherapy trials (PLATO – 1,600 patients, Early ACS - 1800 patients, and CLARITY- 3000 patients) with both NIH and pharmaceutical company sponsorship. After serving as the core laboratory for more than 50 angiographic studies, PERFUSE has extensive experience assessing flow, perfusion, and lesion complexity as well as with performing computerized QCA analysis.
The Core Laboratory and Data Coordinating Center have also demonstrated the ability to maintain patient confidentiality as well as turn around angiographic analysis within a two week period. Dr. Gibson, the director of the laboratory, developed many of the quantitative measures used in angiography. Angiographic assessment will be performed by certified quantitative angiographers with more than two years’ experience and will be reviewed by certified a quantitative angiographic physician over readers with advanced training in cardiovascular medicine.