China Atrial Fibrillation With Complex Metabolic Disorder Cohort Study (CAME Cohort)
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: Atrial Fibrillation (AF), Metabolic Disorders. 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
China Atrial Fibrillation With Complex Metabolic Disorders Cohort Study (CAME Cohort)
Overview
The number of atrial fibrillation (AF) patients in China is approximately 32.76 million, with a prevalence rate of 2.3%. AF is associated with severe outcomes such as stroke and heart failure. Metabolic disorders (e.g., obesity, diabetes mellitus, dyslipidemia) are closely linked to the onset and prognosis of AF. However, the epidemiological characteristics and disease burden of AF combined with metabolic disorders in China remain unclear. Additionally, the impact of complex multi-dimensional metabolic disorders on AF prognosis requires further investigation, and current clinical guidelines lack targeted management recommendations for this population.
Primary outcome measures
- Major Adverse Cardiovascular Events (MACE) [Time frame: From enrollment to the end of follow-up at 5 years]
Secondary outcome measures (4)
- Cardiovascular mortality [Time frame: From enrollment to the end of follow-up at 5 years]
- Cognitive impairment assessed by the Mini-Mental State Examination (MMSE) scale [Time frame: From enrollment to the end of follow-up at 5 years]
- Quality of life: Assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire [Time frame: From enrollment to the end of follow-up at 5 years]
- Atrial fibrillation (AF) treated with catheter ablation for 2 or more times [Time frame: From enrollment to the end of follow-up at 5 years]
Eligibility criteria
Inclusion criteria
- Meet the diagnostic criteria for atrial fibrillation: Single-lead electrocardiogram (≥30 seconds) or 12-lead electrocardiogram (≥10 seconds) shows disappearance of P waves, replaced by fibrillation waves (f waves) with irregular amplitude, morphology and duration, and absolutely irregular RR intervals.
- Aged ≥ 18 years.
- Willing to sign the informed consent form and cooperate with long-term follow-up.
Exclusion criteria
- Suffering from infective endocarditis or myocarditis.
- Having clear etiological factors of atrial fibrillation caused by hyperthyroidism, and the etiology has not been effectively controlled.
- Suffering from severe mental illness and being unable to comply with the study requirements.
- Pregnant women.
- Patients with malignant tumors or substance abuse (e.g., cocaine, heroin).
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07309913 · 2025101847