Characterization of Arrhythmia-induced Cardiomyopathy
- Conditions
- Arrhythmia-induced Cardiomyopathy (AiCM)Cardiomyopathy
- Interventions
- Other: Data collection (retrospective study)Other: Data collection (prospective study database)
- Registration Number
- NCT05662293
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief 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.
- Detailed Description
Current studies indicate that AiCM is an under-recognized and an underestimated clinical entity and its prevalence is poorly documented. This project consists of a retrospective longitudinal cohort and case-control study followed by a prospective observational cohort study.
The retrospective pilot study (1200 patients) is to define the incidence of AiCM in patients who presented to the University Hospital of Basel with a reduced left ventricular ejection fraction before or after the diagnosis of an arrhythmia suggestive to lead to an AiCM.
The prospective study part (1500 patients) is to evaluate the predictors of adverse events and re-hospitalizations in patients with a suspicion of AiCM. The diagnosis of AiCM will be established using a "goldstandard diagnosis": 2 independent cardiologists will adjudicate the diagnosis based on all data from the initial hospital stay and follow-up including ECG, laboratory measurements, vital signs, echocardiography, coronary angiography, stress testing and other cardiovascular diagnostic steps. The most likely diagnosis will be chosen among a list of comprehensive, pre-selected choices. In cases of disagreement of the two reviewers, diagnosis will be discussed with a third senior physician and decision made.
In order to optimize the care of patients with AiCM, the researchers intend to determine the prevalence of AICM, evaluate diagnostic criteria that allow an early diagnosis of AICM, and evaluate the current therapeutic management and prognosis of patients with AICM.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2700
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) Data collection (prospective study database) retrospective cohort and case-control study followed by a prospective observational cohort study. Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) Data collection (retrospective study) retrospective cohort and case-control study followed by a prospective observational cohort study.
- Primary Outcome Measures
Name Time Method Change in Major adverse cardiovascular events (MACE) assessment questionnaire at 6 months, 1 year, 2 year and 5 year Follow- up MACE is a composite endpoint of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.
Incidence of AiCM (Prospective part of the study) at 1 year Follow- up Categorization using a "goldstandard diagnosis (GSD)": diagnosis by 2 independent cardiologists based on all data from the initial hospital stay and follow-up. The most likely diagnosis will be chosen among a list of comprehensive, pre-selected choices (Standard operating procedures (SOP) provided to the adjudicators to ensure homogenous knowledge and adjudication process. The booklet will contain information from the guidelines and position papers)
Incidence of AiCM (retrospective part of the study) one time data extraction and analysis at baseline Categorization (based on a diagnostic algorithm) into 4 categories: "Likely AiCM", "possibly AiCM", "unlikely AiCM" and "Diagnostic work-up and longitudinal assessment insufficient to establish diagnosis" done by study team. AiCM will be defined as the presence of a reduced (\<50%) ejection fraction in a transthoracic echocardiography (TTE) with a concomitant diagnosis of an arrhythmia present in the electronic patient's chart 6 months before or after the date of the diagnostic study.
- Secondary Outcome Measures
Name Time Method Percentage of patients in whom a diagnosis of AiCM could not surely be established and/or where an overlap with another cause of cardiomyopathy was present per goldstandard diagnosis. (prospective part) up to 5 years Data generated by patient's chart review and automated IT export
Frequency of hybrid (both antiarrhythmics and ablation) or a sequential (first anti-arrhythmic and then ablation) therapeutic options (prospective part) one time data extraction and analysis Data generated by patient's chart review and automated IT export
Number of patients with tachymyopathies (prospective part) up to 5 years supraventricular tachycardias such as atrial fibrillation, atrial flutter or atrial tachycardia vs premature-ventricular complex induced arrhythmia-induced cardiomyopathy versus right-ventricle pacing induced arrhythmia-induced cardiomyopathy
Change in European Quality of Life 5 Dimensions (EQ-5D-5L) quality of life (QoL) questionnaire in patients with and without a arrhythmia-induced cardiomyopathy (prospective part) at 6 months, 1 year, 2 year and 5 year Follow- up The EQ-5D-5L consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels. The patient is asked to indicate his/her health state by ticking the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.Percentage of patients in whom a diagnosis of AiCM could be diagnosed or excluded with certainty per goldstandard diagnosis. (prospective part) up to 5 years Data generated by patient's chart review and automated IT export
Percentage of patients in whom the goldstandard diagnosis procedures came to a different diagnosis than the one done by the clinician. (prospective part) up to 5 years Data generated by patient's chart review and automated IT export
Trial Locations
- Locations (1)
University Hospital Basel, Department of Cardiology
🇨🇭Basel, Switzerland