Data Analysis and Evaluation of the Incidence of Life-threatening Ventricular Arrhythmias in Pati… (NCT06883383) | Clinical Trial Compass
CompletedNot Applicable
Data Analysis and Evaluation of the Incidence of Life-threatening Ventricular Arrhythmias in Patients with Newly Diagnosed Cardiomyopathies of NICM or MI/CAD Origin PROTECTED from SCD by a WCD
Germany19,598 participantsStarted 2021-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exclusion criteria will be applied.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of SCD/SCA
Timeframe: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months