Cardiogenic Shock Registry powered by Get With The Guidelines® FAQs
Registry Eligibility
What types of hospitals are you looking to join?
Enrollment is open to any hospital who would like to participate and has capacity to enter all patients treated for cardiogenic shock. The registry is capturing patient data, procedural data (e.g., PCI, ECMO, etc.), vitals, labs, and clinical outcomes for cardiogenic shock patients. If your site has a strong interest, please reach out as soon as possible to [email protected].
What is the patient population for the registry?
All hospitalized patients ≥18 years old who are treated for cardiogenic shock (for example ICD-10-CM code R57.0 among discharge diagnosis).
Does my site need IRB approval to participate?
Similar to the 91视频’s existing suite of Get With The Guidelines® (GWTG) programs, the Cardiogenic Shock registry is a Quality Improvement program and data are collected and submitted as part of standard healthcare operations.
Most hospitals participating in the other GWTG registries as well as this patient data registry do not require institutional review board (IRB) review. Each hospital IRB will determine whether participation is subject to, or exempt from, IRB oversight.
The U.S. Department of Health & Human Services offers a of Quality Improvement Activities FAQs that may help answer your specific IRB questions.
Can the registry data elements be customized for my hospital’s specific needs?
The registry allows institutions to create up to 50 custom data elements. This feature allows for multiple formats, including single and multi-select, dates, continuous variables, and many more. Your institution can also specify allowable parameters for each data element to establish data quality checks. Institutions across AHA registries use this feature to support data capture for their own quality improvement initiatives and research.
The AHA also supports multi-site customizations for studies and state and regional initiatives on a case-by-case basis. For more information, contact [email protected].
Joining the Registry
Is there a cost for the registry?
The registry is free.
How do hospitals enroll in the Cardiogenic Shock Registry?
Hospitals need to complete an Upon completion, AHA staff will review and reach out to the contacts listed in the form to provide additional details about participating and contracting requirements. Contracting for the registry includes:
NON-Get With The Guidelines Hospitals:
Hospitals not already contracted for one of the GWTG programs will need to execute an online Unified Participation Agreement (UPA).
Existing Get With The Guidelines Hospitals who have a UPA with AHA:
Hospitals already contracted for GWTG through the AHA UPA may:
- Sign an amendment to the UPA to add enrollment in the Cardiogenic Shock Registry; or
- Sign a paper amendment to the UPA; or
- Complete an online UPA solely for enrollment in the Cardiogenic Shock Registry.
- Execute a UPA with AHA to transition all of their modules under the UPA; or
- Complete an online UPA solely for enrollment in Cardiogenic Shock Registry.
What if my hospital needs to withdraw after joining the registry?
Hospitals may withdraw at any time, however prior to registering we ask that they assess staffing resources to ensure they are able to meet the data extraction requirements.
Submitting Records
What data are you tracking in the registry?
The registry captures patient demographic and clinical characteristics, interventions, and outcomes in patients hospitalized with cardiogenic shock. Below is a high-level summary of the data captured.
| Category | Examples |
| Demographics | sex, race/ethnicity, age |
| Medical history | heart failure, diabetes, hypertension |
| Medications (prior to admission) | ACE inhibitor, beta blocker, anti-platelets |
| Admission vital signs | height, weight, blood pressure |
| Laboratory data | lactate, serum creatinine, pH |
| Cardiac testing | ejection fraction, invasive hemodynamic data |
| Interventions | CABG, PCI, mechanical circulatory support device(s) |
| Outcomes | complications, survival |
How much time does it take to abstract a patient record?
Abstraction times range from 30 – 45 minutes per record, which is in-line with abstraction time in the other GWTG programs. The CRF was designed to collect minimum necessary data to understand quality of care and outcomes in hospitalized cardiogenic shock patients. Abstraction time may vary depending on the individual case and how accessible the information is in a site’s EMR.
I'm unsure if my institution collects all the information asked on the CRF. Can I still participate?
Yes, however some elements are required and will need to be completed in order to mark the form complete. Response options such as "Unavailable" or "Not Documented" are offered throughout to aid in instances in which your hospital may not have access to certain information.
Can a site sample patients or upload a subset of cardiogenic shock patients to the registry?
No, hospitals must commit to entering ALL patients treated for cardiogenic shock. This means completing consecutive case entry, not a sample. While this may be burdensome for some hospitals, allowing for sampling could introduce bias and confound later findings.
Is there a way to automate data from a hospital EMR, or other database to the registry?
Yes, we will assist you in assessing a variety of interoperability options that will be available for the registry. There is an upload function, which allows sites to upload a .csv or .xls file. Please contact [email protected] to receive additional information.
Will cases entered into other GWTG modules auto-populate overlapping fields in this registry?
At this time, cross-module data population is not available in the Cardiogenic Shock Registry. However, we are exploring interoperability options with other GWTG modules.
May I enter retrospective data?
It is not a requirement to do so. However, hospitals may abstract retrospective data as far back as resources permit.
Accessing the Registry Data for Research
When will data be available to research?
The Cardiogenic Shock Registry data will be available to participating sites for research. Sites are able to analyze and pull reports of their own real-time data from the registry tool at any time. See question below for how to gain access to the full national registry data
How can researchers access the data?
Once a national dataset is available, researchers at hospitals participating in the Cardiogenic Shock Registry, may request access to the data by submitting a research proposal with specific aims to [email protected]. Proposals will be accepted on a rolling basis and will be reviewed by the Cardiogenic Shock Steering Committee. Proposals will be blindly scored on the basis of priority, novel contribution to the scientific literature, feasibility with the data collected, and merit. Approved projects will be paired with a Cardiogenic Shock Steering Committee mentor for the duration of the study. Investigators with approved proposals will access the most recent data on the (PMP), a robust cloud-based computing tool that facilitates collaborative research.
No unauthorized data analyses may be conducted using the Cardiogenic Shock Registry without proposal review by the Cardiogenic Shock Steering Committee and written approval from the 91视频. All publications must follow AHA’s publication guidelines.
