Characterization of Arrhythmia-induced Cardiomyopathy (NCT05662293) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of Arrhythmia-induced Cardiomyopathy
Switzerland2,700 participantsStarted 2021-06-10
Plain-language summary
The goal of the this observational study is to gather clinically available data on patients presenting with a suspicion for arrhythmia-induced cardiomyopathy (AiCM) at the University Hospital Basel.
Who can participate
Age range18 Years
SexALL
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Prospective part
Inclusion Criteria:
* Diagnostic or suspicion of AiCM as presence of specified keyword in patient's file or as screened by colleagues of the internal medicine or cardiology clinics
* Signed study consent
Exclusion Criteria:
* Patient's active refusal of the general consent of the University Hospital Basel
* Age \<18 years old
* Temporary exclusion criteria: Acute health condition such as myocardial infarction, patients presenting with a major trauma, a sepsis, patients shortly after cardiac surgery, and patients in shock (\>100 bpm, \<90 systolic BP, evidence of organ dysfunction).
* Life expectancy \<1 year (palliative, terminal cancer)
Retrospective part
Inclusion Criteria:
* Patients with a reduced left-ventricular ejection fraction (LVEF ≤50%) or a reduction of 15% in the ejection fraction (EF) between two echocardiographies and a concomitant diagnosis of any arrhythmia likely to lead to AiCM within one year before or after diagnosis of the reduced LVEF from 2010-2021
Exclusion Criteria:
* Age \< 18 years old
* Patient's active refusal of the general consent of the University Hospital Basel
* Acute event clearly leading to an acutely reduced LVEF (massive type I myocardial infarction, cardiogenic shock from a coronary or myocardial etiology, septic shock leading to toxic myopathy, hypovolemic shock with reduced EF, cardiac arrest and/or need for resuscitation).
* Patients with life expectancy \<1 year (palliative, terminal cancer)
What they're measuring
1
Incidence of AiCM (retrospective part of the study)
Timeframe: one time data extraction and analysis at baseline
2
Incidence of AiCM (Prospective part of the study)
Timeframe: at 1 year Follow- up
3
Change in Major adverse cardiovascular events (MACE) assessment questionnaire
Timeframe: at 6 months, 1 year, 2 year and 5 year Follow- up