MACEintrag

MACEintrag refers to a standardized data record used within clinical studies and registries to document Major Adverse Cardiovascular Events (MACE). It is created to facilitate consistent capture and analysis of cardiovascular safety and outcome data across trials and observational studies.

A MACEintrag typically records a specified adverse event that meets predefined criteria for a major cardiovascular outcome. Common components of MACE include nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death, with some definitions also incorporating hospitalization for heart failure or urgent revascularization. Each entry links to the patient and the study, and includes information needed to verify the event.

Key data fields in a MACEintrag usually include an event identifier, patient identifier, study identifier, date of event, type of event, and the clinical criteria used for confirmation. Additional fields may cover adjudication status, adjudicator or clinical events committee reference, source documents (such as medical records or death certificates), location of the event, and any relevant laboratory or imaging findings. The record may also note the timing relative to randomization or treatment exposure.

The creation and management of MACEintrag entries typically involve data collection from trial sites, centralized adjudication by an independent committee, and quality control to ensure consistency. These records support time-to-event analyses and safety assessments, contributing to regulatory submissions and scientific reporting. Limitations include definitional variability across studies, potential misclassification, and reliance on available source documentation.

In relation to broader research terms, MACEintrag supports standardized reporting of MACE endpoints and helps enable cross-study comparisons and meta-analyses.