Clinical Trials

Overview

About this study

The TRACER-ICD Study will be a 60 month study (9 months preparation, 45 months to conduct the study, 6 months data analysis and manuscript preparation) in which a prospective cohort of 500 patients receiving ICDs as part of clinical care at 5 sites will be followed for up to 18 months or death, with data collected from patient or proxy interviews (baseline, in-person; quarterly, by telephone) and electronic record reviews (baseline and quarterly), including remote monitoring data. Data collected through these complementary methods will be used to describe the following aspects of patients’ clinical course:

• focused geriatric assessment (e.g., frailty, cognition, functional status);
• comorbidities;
• quality of life;
• advance care planning;
• health services use;
• SDM;
• ICD-recorded physical activity (minutes/day).
• Factors associated with death and poor quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] score < 60 or decline by > 10) will be identified. Group-based trajectory modeling will be used to identify clusters of patients with distinct trajectories of functional status and quality of life following ICD implantation (Aim 1). We will validate our semi-competing risks model to jointly assess ICD shocks and survival (Aim 2). Lastly, we will combine quantitative data on SDM experiences from the main cohort with semi-structured interviews of cardiologists and patients to evaluate strategies for incorporating personalized profiling into SDM (Aim 3).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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