Rajaie Cardiomyopathy and Myocarditis Registry

The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. Rajaie Cardiomyopathy and myocarditis Registry 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 and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry

Study Overview

• Status: Recruiting
• Conditions: Clinical Characteristics; Natural History; Long-term Outcomes; Current Therapeutic Approaches

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Behshid Ghadrdoost, PhD; Phone Number: +982123923017; Email: behshid.ghadrdoost@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Behshid Ghadrdoost
    • Contact: Behshid Ghadrdoost, PhD; Phone Number: +982123923017; Email: behshid.ghadrdoost@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis

Description

Inclusion Criteria:

1. age greater than one year
2. documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria
3. able to give informed consent or in the case of child consent from a parent

Exclusion Criteria:

Patients who have not consent to participate in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admissions to hospital	Number of hospitalizations for cardiovascular reasons	1 year
Development of chronic heart failure	significant decrease in left ventricular ejection fraction	1 year
Prevalence of Stroke/Transient ischemic attack	At least 80% CT/MRI verification of the diagnosis of ischemic stroke/Transient ischemic attack, within the first week of stroke onset	1 year
Incidence of sudden death	unexpected death from a cardiovascular cause in a person with or without preexisting heart disease	1 year
Incidence of heart trasplantation	Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to current therapeutic approaches	Implantable cardioverter defibrillator implantation, Cardiac resynchronisation therapy, septal myectomy, ablation, cardiac transplantation and medications	1 year

Collaborators and Investigators

• Sponsor: Rajaie Cardiovascular Medical and Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Anticipated): November 11, 2020
• Study Completion (Anticipated): November 11, 2025

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: March 7, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Myocarditis; Cardiomyopathies
• Other Study ID Numbers: registry_98118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No