Cardiomyopathy (Ischemic or Non-Ischemic)
Conditions
Keywords
sudden cardiac arrest, sudden cardiac death, non-ischemic cardiomyopathy, dilated cardiomyopathy, wearable cardioverter-defibrillator, left ventricular ejection fraction, ischemic cardiomyopathy
Brief summary
SCD-PROTECT is an epidemiological, observational, multicenter study to assess the incidence of sudden cardiac arrest/death (SCA/SCD) in patients with newly diagnosed non-ischemic cardiomyopathy or with myocardial infarction/coronary artery disease. Data on SCA/SCD risk in the early phase of disease, especially during medication up-titration while left ventricular ejection fraction is reduced, are sparse.
Detailed description
SCD-PROTECT is an epidemiological, observational, multicenter study, evaluating the incidence of sudden cardiac arrest (SCA) / sudden cardiac death (SCD) in patients with reduced left ventricular ejection fraction (LVEF) due to newly diagnosed non-ischemic cardiomyopathy (NICM) or a myocardial infarction/coronary artery disease with intervention (MI/CAD). In the early phase (3 months) during up-titration of guideline-recommended therapy (GRMT) a wearable cardioverter defibrillator (WCD) can be indicated due to increased risk for SCA/SCD in these patients. The WCD provides continuous arrhythmia monitoring, detection of life-threatening ventricular arrhythmias, and provides automatic defibrillation within a minute of detection of a potentially fatal ventricular tachyarrhythmia whatever the cause of increased risk of SCD. Currently, detailed data for risk of SCA/SCD in patients with NICM or MI/CAD during the early phase are sparse. The SCD-PROTECT study is a comprehensive, nationwide analysis of at least 18.000 consecutive patients using a WCD (LifeVest®, ZOLL, Pittsburgh, PA, USA) in Germany to evaluate the risk of SCA/SCD in the early phase of disease. All patients who received a WCD (LifeVest®, ZOLL, Pittsburgh, PA, USA) from December 2021 to May 2023 in Germany will be screened for inclusion. Observation period will start with first ECG recording of the WCD and terminates with individual end-of-WCD-use. Primary objective is the SCA/SCD incidence, measured by the percentage of patients with at least one appropriate treatment (appropriate shock) delivered and automatically recorded by WCD. The incidence density of appropriate shocks per 100 patient years will also be calculated. Secondary objectives include inappropriate WCD treatments, mortality and side effects during WCD wearing time. Exploratory objectives are trajectory of LVEF, compliance with WCD use, time to first appropriate shock from beginning of wearing time until first WCD shock and incidences of appropriate shocks (primary endpoint) by subtype of NICM or MI/CAD. NICM and MI/CAD sub-types are categorized by the investigator team at baseline and may include the following: DCM, Myocarditis, PPCM, Tako-Tsubo CM, Tachymyopathy, Toxic CM, Sarcoidosis Genetic/Congenital, and others vs. Post Myocardial Infarction, Coronary Heart Disease and others. Patient data are extracted from routinely collected medical records by analysts, blinded to the outcomes.
Interventions
None listed
Sponsors
Zoll CMS GmbH
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be 18 years of age or older. * Subjects must be prescribed a WCD for a high risk of SCD. * Subjects must have been fitted with a WCD, and a baseline for ECG-analysis must have been established. * Subjects must have worn the WCD; time zero of inclusion is the activation of the ECG. * Subjects must have had a diagnosis of newly diagnosed NICM or MI/CAD with reduced LVEF as indication for WCD prescription.
Exclusion criteria
* No specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SCD/SCA | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Incidence of patients with NICM or MI/CAD with at least one appropriate treatment (appropriate shock) observed during WCD-use. Treatment events will be automatically recorded through the monitoring device. The incidence density of appropriate shocks per 100 patient years will also be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Percentage of death during observation period |
| Incidence of inappropriate shocks | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Percentage of patients with inappropriate shocks observed during WCD-use. Events will be automatically recorded through the monitoring device. |
| Adverse events | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Adverse events during observation period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average WCD wear-time in days | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Average WCD wear-time in days, from baseline until end of WCD-use, measured in days |
| Trajectory of left ventricular ejection fraction (LVEF) | Pre-hospital (up to one year), at hospital discharge (assessed up to 3 days), and at end of WCD use (an average of 2-3 months from base line) | Trajectory of left ventricular ejection fraction (LVEF), measured in percent LVEF at the time-points pre-hospital, at hospital discharge (corresponding to baseline of WCD-use), and at end of WCD-use |
| WCD compliance | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Compliance, meaning average wear-time of the WCD per day, measured in hours per day. |
| Cumulative Incidences of appropriate treatments per sub-etiologies | Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months | Cumulative Incidences of appropriate treatments per sub-etiologies, measured in events per 100 patient-years |
| Time from baseline of WCD-use until first appropriate WCD-treatment | From baseline of WCD-use until first appropriate treatment by the WCD, assessed through end of WCD use, an average of 2-3 months | Time from baseline of WCD-use until first appropriate WCD-treatment, measured in days |
Countries
Germany
Outcome results
None listed