Table 3.
Variable | Hospital Day 1 | Discharge | 2 wks (1<3 wks) | 6 wks (3–9 wks) | 3 mo (1–6 mo) | 6 mo (9 wks–1 yr) | 1–5 Years |
---|---|---|---|---|---|---|---|
Demographics | X | ||||||
Medical History1 | X | X | X | X | X | X | |
Echocardiogram | X | X | X | X | X2 | X2 | |
ECG | X | X | X | X | X | ||
CMR and exercise test (LVEF <45%) | X | ||||||
Clinical Labs3 | X | X | X | X | X | ||
Research Labs4 | X | X | X | X | X |
ECG=Electrocardiogram; CMR=Cardiac magnetic resonance imaging; LVEF=Left ventricular ejection fraction
Medical history will include complete cardiac and non-cardiac systems review; Functional Status Score (FSS) will be measured Day 1, Discharge, and 2 weeks, 6 weeks, and 6 months; PROMIS instrument at 2 weeks, 6 weeks, 6 months, and annually.
Echocardiograms at 6 months and annually between years 1 and 5 are optional in patients who have previously had two consecutive normal echocardiograms, though the study will collect information on clinical cardiology visits beyond the 6-month window, and also will complete annual medical history forms for years 1–5, to bring follow-up to up to 5 years after presentation.
We will collect and analyze all data obtained as part of routine care. Although we will not mandate specific laboratory tests in the research protocol, we recommend based upon best clinical evidence to date that patients have lab testing that includes at a minimum the following tests until they have normalized: CBC and differential (for absolute lymphocyte count and neutrophil/lymphocyte ratio), platelets, ESR, CRP, ferritin, D-Dimers, procalcitonin (if the center performs this), ALT, BNP and troponin.
Biospecimens for the PHN biobank for future whole genome sequencing in patients who give consent for this can be obtained at any point within the first year of enrollment. Other research laboratory tests may be drawn at the time of blood draws based upon the patient’s participation in protocols in addition to the MUSIC study within their clinical center if they have signed the study-specific informed consent form.