China Atrial Fibrillation With Complex Metabolic Disorder Cohort Study (CAME Cohort)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiangya Hospital of Central South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Meets the diagnostic criteria for AF: single-lead electrocardiogram (ECG) ≥ 30 seconds or 12-lead ECG ≥ 10 seconds, with disappearance of P waves, presence of fibrillatory (f) waves, and absolute irregularity of RR intervals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,459 Participants
are grouped into 3 trial groupsGroup A: No metabolic disorder
Group B: Single metabolic disorder
Group C: Complex metabolic disorder (≥2 types)
Trial outcomes
Primary outcomes
1
Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events (MACE) - Composite outcome including the following components, all assessed during the entire follow-up period: * All-cause mortality: Defined as any death regardless of cause, confirmed by death certificate, medical records or family report. * Stroke: Defined as acute focal neurological deficit lasting ≥24 hours (or leading to death within 24 hours) due to cerebral infarction or intracerebral hemorrhage, confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI). * Heart failure-related hospitalization: Defined as hospitalization requiring inpatient treatment due to worsening heart failure symptoms (e.g., dyspnea, edema), with objective evidence of heart failure exacerbation (e.g., elevated BNP, pulmonary congestion on chest imaging).
Time frame
From enrollment to the end of follow-up at 5 yearsSecondary outcomes
1
Cardiovascular mortality
Defined as death caused by cardiovascular diseases (including myocardial infarction, heart failure, stroke, arrhythmia, etc.), determined by review of death certificate, autopsy report or clinical records by the endpoint adjudication committee.
Time frame
From enrollment to the end of follow-up at 5 years2
Cognitive impairment assessed by the Mini-Mental State Examination (MMSE) scale
Defined as a score ≤23 on the Mini-Mental State Examination (MMSE) scale at follow-up visits, with cognitive decline confirmed by a neuropsychological assessment panel if necessary (MMSE covers orientation, memory, attention, calculation, language and motor functions).
Time frame
From enrollment to the end of follow-up at 5 years3
Quality of life: Assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire at baseline, 6 months, 12 months and annually thereafter; total score ranges from 0 (worst quality of life) to 100 (best quality of life), with subscores for symptoms, activity, treatment concern and quality of life reported separately.
Time frame
From enrollment to the end of follow-up at 5 years4
Atrial fibrillation (AF) treated with catheter ablation for 2 or more times
Defined as receiving a second or subsequent catheter ablation procedure due to AF recurrence after the initial ablation, documented by interventional procedure records.
Time frame
From enrollment to the end of follow-up at 5 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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