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

NCT07309913 | Not Yet Recruiting

• 1 other identifier: 2025101847
• Study Type: observational
• Target: 3,459
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF); Metabolic Disorders

Outcome Measures

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).

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

Secondary Outcomes (4)

• Cardiovascular mortality

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

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

  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

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

• Atrial fibrillation (AF) treated with catheter ablation for 2 or more times

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

Study Arms (3)

No metabolic disorder

Single metabolic disorder

Complex metabolic disorder (≥2 types)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood

MeSH Terms

Conditions

Atrial Fibrillation; Metabolic Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 30, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2036
• Study Completion (Estimated): June 1, 2036
• Last Updated: December 30, 2025

Record last verified: 2025-11