Study Protocol

Rajaie Cardiomyopathy and Myocarditis Registry: protocol for an observational study

Rajaie Cardiomyopathy and Myocarditis Registry

Abstract

Background: Cardiomyopathies are characterized by structural and functional abnormalities of myocardium that will probably lead to premature death from arrhythmia and/or progressive heart failure. Myocarditis is an inflammatory disease of the myocardium diagnosed by histological criteria definitively. To date, most information about the natural history and management of cardiomyopathies and myocarditis has derived from cohort studies in a small number of specialized centers.

Aim: The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center from all over the country is remarkable.  Rajaie Cardiomyopathy and myocarditis Registry (RCMR) study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry. Covid 19 Myocarditis and its sequence as cardiomyopathy seems a new challenge in forthcoming years.

Methods: Patients with a history of documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis and willing and able to give informed consent or in the case of child consent from a parent will be included. At baseline visit , past medical history, clinical signs/ symptoms, risk factors, physical examination and family history of cardiomyopathy, as well current standards for diagnostic workup and clinical follow-up and where relevant electrocardiogram, echocardiography, cardiac magnetic resonance, Holter monitoring, or  biomarker analyses will be checked. Based on the type of disease and the physician's opinion, patients will undergo exercise test, electrophysiology study or endomyocardial biopsy. Outcome and results of various therapeutic approaches currently employed for patients including implantable cardioverter defibrillator, cardiac resynchronization therapy, septal myectomy, ablation, cardiac transplantation and medications will be assessed. Long-term outcomes including the benefits and complications of therapeutic interventions will be collected. Follow-up visit will be scheduled after 12 months for all patients and survival status, hospitalizations, co-morbidities, medications will be assessed. Data will be collected on a research electronic data source (Regitory) and will be analyzed at regular intervals based on study objectives and also by using artificial intelligence.

Conclusion: RCMR aims to make a major contribution to understanding the natural history of the cardiomyopathy/ myocarditis, as well as guiding evidence-based decision making. Potential gaps with existing recommendations will be discussed as well as some suggestions for improvement of health care provision.

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IssueVol 59, No 5 (2021) QRcode
SectionStudy Protocol
Published2021-07-05
DOI https://doi.org/10.18502/acta.v59i5.6659
Keywords
Registry protocol cardiomyopathy myocarditis

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How to Cite
1.
Maleki M, Noohi F, Sadeghipour P, Peighambari MM, Amin A, Samiee N, Haghjoo M, Rezaeian N, Mazloomzadeh S, Baghizadeh E, Rafiee F, Ghadrdoost B. Rajaie Cardiomyopathy and Myocarditis Registry: protocol for an observational study. Acta Med Iran. 59(5).