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China Atrial Fibrillation With Complex Metabolic Disorder Cohort Study (CAME Cohort)

China Atrial Fibrillation With Complex Metabolic Disorders Cohort Study (CAME Cohort)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07309913
Acronym
CAME Cohort
Enrollment
3459
Registered
2025-12-30
Start date
2026-02-01
Completion date
2036-06-01
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Metabolic Disorders

Brief summary

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.

Interventions

None listed

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiovascular Events (MACE)From enrollment to the end of follow-up at 5 yearsMajor 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).

Secondary

MeasureTime frameDescription
Cardiovascular mortalityFrom enrollment to the end of follow-up at 5 yearsDefined 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.
Cognitive impairment assessed by the Mini-Mental State Examination (MMSE) scaleFrom enrollment to the end of follow-up at 5 yearsDefined 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).
Quality of life: Assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaireFrom enrollment to the end of follow-up at 5 yearsAssessed 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.
Atrial fibrillation (AF) treated with catheter ablation for 2 or more timesFrom enrollment to the end of follow-up at 5 yearsDefined as receiving a second or subsequent catheter ablation procedure due to AF recurrence after the initial ablation, documented by interventional procedure records.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026