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NCT Number: NCT07309913

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Metabolic Diseases Metabolic Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: From enrollment to the end of follow-up at 5 years

    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).

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: From enrollment to the end of follow-up at 5 years

    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.

  2. Cognitive impairment assessed by the Mini-Mental State Examination (MMSE) scale

    Time frame: From enrollment to the end of follow-up at 5 years

    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).

  3. 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

    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.

  4. 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

    Defined as receiving a second or subsequent catheter ablation procedure due to AF recurrence after the initial ablation, documented by interventional procedure records.

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Acronym: CAME Cohort

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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