TRAjectories and CLinical ExpeRiences of ICD Therapy Study (TRACER-ICD)
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|ClinicalTrials.gov Identifier: NCT05116176|
Recruitment Status : Not yet recruiting
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
|Condition or disease||Intervention/treatment|
|Implantable Defibrillator User||Device: Implantable cardioverter-defibrillators|
Study Objectives and Design
The specific aims, applicable methods, and main hypotheses of the TRACER-ICD study are as follows:
Aim 1: To characterize the clinical course of patients aged >65 after ICD implantation by establishing a multicenter prospective cohort (N=500). Baseline (verbal and in-person) and quarterly (phone, electronic health records [EHR], remote monitoring) data collected up to 18 months or death will include: a. geriatric assessments (e.g. frailty, cognition,1 functional status; b. comorbidities; c. quality of life and symptom burden; d. health services use; e. SDM history; and f. ICD-recorded physical activity (minutes/day).
Factors associated with death and poor quality of life will be identified. Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.
H1: A model integrating frailty and clinical factors will predict (a) death, (b) poor quality of life, and (c) unfavorable functional trajectories after ICD implantation.
Aim 2: To validate a personalized prediction model of treatment outcomes of ICDs. We will apply our established semi-competing risks approach5 to the prospective cohort, enriched by the baseline geriatric assessments, to predict individual patients' probabilities of the following outcome profiles at 6, 12, and 18 months post-implant: a. death without prior shock, b. death with prior shock, c. survival without prior shock, and d. survival with prior shock. The independent contribution of frailty, cognitive dysfunction, baseline quality of life, and functional status (e.g. total deficits in ADL and IADL) to model performance will be evaluated.
H2: Addition of frailty, cognitive dysfunction, quality of life, and functional status to a model with cardiovascular variables will significantly improve model performance as assessed by area under the curve (AUC).
Aim 3: To identify optimal strategies for incorporating personalized outcome profiles into SDM. The main cohort's baseline interview and EHR review will provide quantitative data on past SDM tools used by physicians. We will develop a prototype individualized version of the Colorado SDM tool that incorporates 18-month outcome profiles using our semi-competing risk model. We will perform semi-structured interviews of cardiologists (N=20) as well as patients (N=20) recruited from the main cohort regarding process mapping of SDM from clinic to implant procedure, including timing, content, format preferences, and impressions of the prototype individualized tool.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||TRAjectories and CLinical ExpeRiences of ICD Therapy Study|
|Estimated Study Start Date :||November 2021|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
- Device: Implantable cardioverter-defibrillators
500 patients age >65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs).
- Clinical Trajectories after ICD implantation [ Time Frame: Patients will be followed quarterly for 18 months or to death. ]Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.
- Outcomes after ICD Implantation [ Time Frame: Up to 18 months ]Death/Poor Quality of Life (combined endpoint)
- Semi-competing risks model of deaths and/or ICD shocks [ Time Frame: Up to 18 months ]Personalized outcome profiles for death +/- ICD shocks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116176
|Contact: Daniel B. Kramer, MD, MPHfirstname.lastname@example.org|
|Contact: Lindsay H. Duchesneau, MPAemail@example.com|
|Principal Investigator:||Daniel B Kramer, MD, MPH||Beth Israel Deaconess Medical Center|