Baseline Enrollment & Demographics
Consent metadata, demographics, social determinants of health, insurance, referral source, and screening eligibility.
Starter REDCap project templates and modular CRFs derived from the HIER prospective Data Dictionary. Every instrument is versioned, tagged, aligned with CDISC CDASH, and importable into REDCap, HIER EDC, or any ODM-compliant system.
Consent metadata, demographics, social determinants of health, insurance, referral source, and screening eligibility.
Primary site, histology, stage, biomarkers, prescribed dose, fractionation, treatment intent, and concurrent systemic therapy.
Established CVD, risk factors, medications, vitals, labs, cardiac biomarkers, and validated risk scores (ASCVD, HFA-ICOS).
Full medication reconciliation with RxNorm coding and dose/frequency capture; supports longitudinal update visits.
Planning CT metadata, DICOM linkage, scanner parameters, contrast use, ECG-gating, imaging biomarker QA flags.
Whole heart, LAD, LCx, RCA, chambers, valves, pericardium — mean/max/D0.03cc and dose-volume metrics.
hs-cTnT, NT-proBNP, GDF-15, galectin-3, hs-CRP, ST2, lipids, HbA1c, renal panel at pre-RT, mid-RT, post-RT, 6/12/24/60 months.
Sample IDs, collection tubes, processing times, storage locations, aliquot inventory, shipment manifests.
Standardized PROMIS short forms for physical function, fatigue, dyspnea, sleep, and social participation.
Kansas City Cardiomyopathy Questionnaire (short form) with automated summary scores.
Device linkage, adherence, activity summaries, sleep metrics, heart rate variability, atrial arrhythmia notifications.
CTCAE-graded cardiovascular AEs with MACE adjudication packet: source documents, adjudicator assignment, consensus outcome.
Cardiovascular and oncologic hospitalizations, ED visits, ICU stays, procedures, length of stay, disposition.
Withdrawal reason, final vital status, biospecimen disposition, participant contact preferences for future research.