The global burden of cardiovascular diseases (CVDs) continues to escalate, with acute myocardial infarction (AMI) representing a significant portion of this challenge. Notably, ST-elevation myocardial infarction (STEMI), a severe form of AMI, necessitates prompt and precise management. In response, IQVIA’s OMOP team, in collaboration with international data partners and leading cardiovascular researchers, is initiating a landmark study aimed at enhancing the identification and treatment of STEMI through the utilization of large-scale retrospective real-world data (RWD).

The Imperative for Advanced STEMI Analysis:

In 2019, a staggering 17.9 million people worldwide succumbed to CVDs, accounting for 32% of all global deaths. Among these fatalities, 85% were attributed to AMI, a critical condition characterized by compromised blood flow to the heart muscle. Notably, in the United States alone, an alarming statistic emerges: every 40 seconds, someone experiences an AMI. The annual incidence includes approximately 550,000 new cases and 200,000 recurrent events (1).

The 4th Universal Definition of Myocardial Infarction (UDMI) outlines specific criteria for diagnosing acute ST-elevation myocardial infarction (STEMI). This condition necessitates a rise and/or fall in cardiac troponin (cTn) levels, coupled with clinical evidence of ischemia—such as symptoms, ECG changes, supportive imaging findings, or evidence of coronary thrombus. The underlying aetiology typically involves plaque disruption and coronary atherothrombosis (2,3,4). Acute STEMI can manifest in various ways, including hyperacute T-wave changes, true posterior MI, multi-lead ST depression with concurrent ST elevation in lead aVR, and characteristic diagnostic criteria in the context of left bundle branch block.

Given the urgency in managing acute STEMI cases, there is a critical need for accurate, scalable identification and characterization of this condition across diverse populations. Such insights have far-reaching implications, including resource allocation, targeted awareness campaigns to enhance heart attack recognition, and strategies for improving cardiovascular health and risk factor modification.

Strategic Collaboration for Global Insight:

To address these challenges, IQVIA’s OMOP team (Drs. Milou Brand and Atif Adam) is spearheading a network study with data partners across the European Union (EU), Asia-Pacific (APAC), and the United States. This global, multi-country network study, conducted in conjunction with Dr. Mirza Khan from Saint Luke’s Mid America Heart Institute, aims to identify robust and generalizable phenotypes for acute STEMI cases. By leveraging retrospective, RWD, we seek to unravel the characteristics and incidence rates of patients experiencing acute STEMI across a global federated network.

Federated Network Approach:

In our research endeavour, we will conduct a comprehensive study focused on acute STEMI within a global federated network. This network comprises primary care and secondary care data assets mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).

Let us delve into the key components of this approach:

1. Federated Network: Our study capitalizes on a federated architecture, recognizing the distributed nature of healthcare data sources. Each participating site retains control over its data, ensuring privacy and security. By collaborating across this network, we can perform cross-site analyses without centralizing sensitive patient information.
2. OMOP CDM: The adoption of the OMOP CDM is pivotal. This standardized format harmonizes disparate data elements, providing a consistent framework for representing clinical information. By adhering to shared conventions, we facilitate seamless data exchange and enable researchers to write analysis code that can be uniformly applied across participating datasets.
3. Clinical Coding Systems: The OMOP CDM aligns with standardized clinical coding systems (such as SNOMED CT, ICD-10, and CPT). This ensures uniform representation of medical concepts, enhancing the reliability and interpretability of our analyses.
4. Patient-Level Data Privacy: In alignment with our commitment to privacy,, the study design focuses on the aggregation of results and summary statistics, avoiding the dissemination of individual patient-level data. . This safeguards sensitive information while allowing for robust research insights.

Implications and Objectives:

The primary goal of this study is not merely to advance the scientific understanding of STEMI but to directly impact clinical practice and patient outcomes. Through our collaborative research, we aim to:

1. Enhance Identification Processes: Develop more accurate and scalable methods for identifying STEMI across diverse patient populations, which is crucial for timely and appropriate treatment.
2. Inform Healthcare Strategies: Provide data-driven insights that can inform healthcare policy, resource allocation, and the design of targeted awareness campaigns to improve heart attack recognition and response.
3. Facilitate Treatment Innovation: Contribute to the refinement of treatment protocols and the development of innovative care strategies, ensuring that patients receive the most effective interventions.

Methodological Excellence and Study Design

With a federated approach, IQVIA assumes a pivotal role as the central study coordination centre. Our responsibilities encompass several responsibilities:

1. Study Design Development: IQVIA spearheads the formulation of the study design. This entails planning, alignment of research objectives, and consideration of methodological nuances. Our team collaborates closely with domain experts to ensure robustness and relevance.
2. Data Partner Engagement: We engage with a network of data partners across diverse healthcare settings. Our role extends beyond mere coordination; it involves clarifying protocols, addressing queries, and fostering a collaborative environment.
3. Analytical Package Dissemination: IQVIA shares a comprehensive analytical package with data partners developed by the OHDSI community. This package encapsulates standardized analysis code, methodologies, and guidelines. By sharing the analytical package with the data partners, we allow them to execute analyses on data assets in their local environment.
4. Results Compilation and Review: Aggregated results are sent back from data partners to the IQVIA coordinating centre. Here, we meticulously review findings, validate methodologies, and compile study results.

Through this collaborative effort, IQVIA and its partners aim to catalyse significant advancements in the understanding and management of STEMI, ultimately contributing to the reduction of cardiovascular mortality and the enhancement of patient care globally. This study exemplifies our commitment to leveraging real-world data in pursuit of meaningful, actionable health insights, standing at the forefront of innovation in cardiovascular health research.

Stay tuned for the results!

REFERENCES:

(1) Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics−2016 update: a report from the American Heart Association. Circulation. 2016; 133:e38–360.

(2) Asatryan B, Vaisnora L, Manavifar N. Electrocardiographic Diagnosis of Life-Threatening STEMI Equivalents. JACC: Case Reports. 2019;1(4):666-668. doi:10.1016/j.jaccas.2019.10.030

(3) Bergmark, B. A., Mathenge, N., Merlini, P. A., Lawrence-Wright, M. B., & Giugliano, R. P. (2022). Acute coronary syndromes. The Lancet, 399(10332), 1347–1358. https://doi.org/10.1016/S0140-6736(21)02391-6

(4) Thygesen K, Alpert JS, Jaffe AS, et al. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018;138(20). doi:10.1161/cir.0000000000000617