Atrial Fibrillation (AF)CAME CohortNCT07309913
China Atrial Fibrillation With Complex Metabolic Disorder Cohort Study (CAME Cohort)
An observational study of Atrial Fibrillation (AF) and Metabolic Disorders, run by Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Metabolic Disorders
- How many people
- 3,459 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Jun 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: China Atrial Fibrillation With Complex Metabolic Disorders 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.
- Conditions
- Atrial Fibrillation (AF), Metabolic Disorders
- Medical subject headings
- Atrial Fibrillation, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No metabolic disorder | Not described | |
| Single metabolic disorder | Not described | |
| Complex metabolic disorder (≥2 types) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of follow-up at 5 years
Secondary outcomes (4)
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.
Measured: From enrollment to the end of follow-up at 5 years
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).
Measured: 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
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.
Measured: From enrollment to the end of follow-up at 5 years
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.
Measured: From enrollment to the end of follow-up at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2036 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,459 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309913
- Sponsor's protocol ID
- 2025101847
- Acronym
- CAME Cohort
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Atrial Fibrillation With Complex Metabolic Disorders Cohort Study (CAME Cohort)
- ClinicalTrials.gov ID
- NCT07309913
- Acronym / sponsor ID
- CAME Cohort / 2025101847
- Conditions
- Atrial Fibrillation (AF), Metabolic Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,459 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2036 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No metabolic disorder | – | – |
| Single metabolic disorder | – | – |
| Complex metabolic disorder (≥2 types) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Metabolic Disorders, run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: From enrollment to the end of follow-up at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.