MItral Regurgitation Risk Assessment and CLinical modElling
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Insufficiency, Mitral Regurgitation (MR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)
Overview
Mitral regurgitation (MR) is a common valvular heart disease worldwide, and untreated severe MR is associated with an elevated risk of heart failure and mortality. According to causes, MR could be divided into primary or secondary MR. The risk factors of mortality or heart failure hospitalization in different types of MR patients are under intensive investigation. MItral Regurgitation risk Assessment and CLinical modElling (MIRACLE) study is a prospective cohort study including adult patients diagnosed with ≥ moderate MR during hospitalization. Comprehensive echocardiographic examination was conducted at baseline evaluating valvular heart disease severity, atrial and ventricular systolic/diastolic function, pulmonary artery systolic pressure (PASP), etc. We aim to evaluate the prognostic risk factors of patients with MR and construct a prognostic clinical model to guide clinical decision-making.
Primary outcome measures
- All-cause mortality [Time frame: Through study completion, an average of 5 years]
Secondary outcome measures (2)
- Cardiovascular mortality [Time frame: Through study completion, an average of 5 years]
- Heart Failure Hospitalization (HFH) [Time frame: Through study completion, an average of 5 years]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
- Aged over 18 yrs.
Exclusion criteria
- Patients unable to provide written consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Sun Yat-sen Univerity — Guangzhou
Identifiers
NCT: NCT06876883 · MIRACLE study