As the severity of the coronavirus pandemic began to reveal itself in the United States, the American Heart Association’s Get With The Guidelines (GWTG) quality improvement program took swift action. In a matter of weeks, COVID-19-specific data elements were added to existing GWTG Registry modules for stroke, heart failure, atrial fibrillation, coronary artery disease, and resuscitation. Early reports describing the association of COVID-19 with significant adverse cardiovascular outcomes and serious complications for patients with existing cardiovascular disease (CVD) or CVD risk factors highlighted the urgent need for additional research.
The AHA responded by launching the multicenter COVID-19 CVD Registry, powered by Get With The Guidelines, in April 2020. This registry collects biomarkers, clinical data, and cardiovascular outcomes in COVID-19 patients, allowing participating sites to examine data in real-time and contribute to a database to study the impact of the pandemic for years to come. The robust GWTG registry infrastructure has allowed for rapid data collection, including over 28,000 patient records and nearly 130,000 lab reports, with more than 150 registry sites enrolled .
“Research is key to tracking the effectiveness of treatments and patterns in patient outcomes. Having access to this rapidly growing data set provides the potential for multiple teams to develop simultaneous breakthroughs on multiple fronts,” explains James de Lemos, M.D., co-chair of the steering committee for the registry and professor of medicine and the Sweetheart Ball-Kern Wildenthal, M.D., Ph.D., Distinguished Chair in Cardiology at the University of Texas Southwestern Medical Center in Dallas. “This is instrumental in helping health care professionals gather the evidence needed to rapidly adjust protocols for COVID-19 patients and reflects the importance of the American Heart Association’s COVID-19 CVD registry.”
As a quality improvement program, investigator-led research opportunities using the aggregate, national dataset were initially provided to investigators at institutions participating in the Registry. These early studies have already provided a robust source of data to inform clinical practice to potentially improve patient outcomes. Late-breaking advances were presented at AHA’s Scientific Sessions, describing initial results from the registry including racial and ethnic differences in treatment and outcomes and association of body mass index with cardiovascular outcomes in COVID-19 patients. Several additional studies will be published in the peer review literature in the coming weeks and months.
The AHA is pleased to now offer COVID-19 CVD Registry research opportunities to the broader research community, regardless of registry participation. Proposals will be accepted on a rolling basis in 2021 and will be evaluated on priority, novel contribution to the scientific literature, feasibility with the data collected, and merit.
Proposal and review process:
- Prior to drafting and submitting a research proposal, please review the data elements collected in the COVID-19 CVD Registry's Case Report Form (CRF) to ensure study feasibility of the analysis based on the data collected in the Registry.
- Download and complete a COVID-19 CVD Registry Proposal Form
- Submit the proposal to the American Heart Association at email@example.com
- Proposals will be reviewed on a rolling basis by the American Heart Association COVID-19 Research and Publications (R&P) Committee and will be evaluated on priority, novel contribution to the scientific literature, feasibility with the data collected, and merit.
- Each approved project will be assigned a liaison from the R&P Committee to support the project from proposal to publication.
In alignment with AHA’s efforts to accelerate research impact and streamline research collaboration, this data will be made available on the AHA Precision Medicine Platform (PMP). This cloud-computing platform, hosted by the AHA Institute for Precision Cardiovascular Medicine, offers secure workspaces equipped with state-of-the-art analytical tools.
- Proposed analyses should be completed within four weeks of access to data on the Precision Medicine Platform.
- Researchers who have a web-based SAS license or are familiar with other programming languages can conduct their approved analyses in a secured workspace on the Precision Medicine Platform.
- Researchers may also connect with American Heart Association Data Scientists who offer consultative data analytics services to conduct the approved statistical analysis on the Precision Medicine Platform.
After completing the proposed analysis of the COVID-19 CVD Registry data, researchers will draft the findings for a peer-reviewed manuscript.
- The study's lead author will secure approval from all co-authors prior to submitting the manuscript for final approval by the Steering Committee and American Heart Association Science.
- Manuscripts should be drafted and submitted for Steering Committee approval within eight weeks of access to data on Precision Medicine Platform.
Note: No unauthorized data analyses may be conducted using the COVID-19 CVD Registry without proposal review by the AHA COVID-19 Steering Committee and written approval from the American Heart Association. All publications must follow AHA’s Quality Improvement Program publication guidelines. More information is available at www.heart.org/qualityresearch.