Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2700 participants
OBSERVATIONAL
2021-06-10
2027-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)
retrospective cohort and case-control study followed by a prospective observational cohort study.
Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)
Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part). The assessment will be done via mail, letter or phone
Data collection: Quality of Life (QoL) Questionnaire (prospective part)
Data collection: Quality of Life (QoL) Questionnaire (prospective part). The questionnaire "EQ-5D-5L questionnaire" will be used to assess quality of life.
Data collection (retrospective study)
Anonymized search and review of patients electronic health records of the University Hospital of Basel for patients with a reduced LVEF and a concomitant (±1year or after any observation of a reduced LVEF in imaging) diagnosis of arrhythmia known to be causing AiCM.
Data collection (prospective study database)
Data collection on alcohol consumption, family history, rhythm disorder, hospitalizations, cardiac assessments, adverse events at baseline, 6 months, 1 year, 2 years and 5 years.
Interventions
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Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)
Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part). The assessment will be done via mail, letter or phone
Data collection: Quality of Life (QoL) Questionnaire (prospective part)
Data collection: Quality of Life (QoL) Questionnaire (prospective part). The questionnaire "EQ-5D-5L questionnaire" will be used to assess quality of life.
Data collection (retrospective study)
Anonymized search and review of patients electronic health records of the University Hospital of Basel for patients with a reduced LVEF and a concomitant (±1year or after any observation of a reduced LVEF in imaging) diagnosis of arrhythmia known to be causing AiCM.
Data collection (prospective study database)
Data collection on alcohol consumption, family history, rhythm disorder, hospitalizations, cardiac assessments, adverse events at baseline, 6 months, 1 year, 2 years and 5 years.
Eligibility Criteria
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Inclusion Criteria
* Signed study consent
* 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
* Life expectancy \<1 year (palliative, terminal cancer)
Retrospective part
* 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)
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Patrick Badertscher, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Department of Cardiology
Locations
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University Hospital Basel, Department of Cardiology
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-00873; kt22Badertscher2
Identifier Type: -
Identifier Source: org_study_id
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