Cardiopulmonary Exercise Active Health Cohort Study (CEAHCS)
This is a multicenter, prospective, observational cohort study. Study participants will first be enrolled into the general population main cohort, and some eligible subjects will be invited to participate in a validation study for the consistency of estimated VO₂max. The overall study consists of the establishment of the main cohort and three major research modules: cardiovascular endpoint risk prediction, early warning of exercise-related cardiovascular event risk, and health reminder and behavioral feedback. In addition, a substudy is designed to enroll 300 patients with stable metabolic cardiovascular disease, aiming to verify the consistency between wearable-device-estimated maximal oxygen uptake (VO₂max) and the gold standard of Cardiopulmonary Exercise Testing (CPET), so as to evaluate the applicability and error structure of the device-estimated parameters in clinical populations.
Visão geral do estudo
Status
Descrição detalhada
To establish a prospective cardiopulmonary exercise and active health cohort based on wearable devices, systematically integrate continuous dynamic physiological and behavioral data as well as standardized clinical outcome information, and evaluate the application value of wearable-device-derived metrics in dynamic cardiovascular risk assessment and exercise-related risk identification. Specific objectives are as follows:
- To verify the agreement between wearable-device-estimated VO₂max and CPET measurements.
- To assess the association between continuously monitored wearable metrics and Major Adverse Cardiovascular Events (MACE), and develop a long-term risk prediction model.
- To evaluate the relationship between short-term physiological change features during exercise or physical activity and exercise-related cardiovascular events, and explore methods for dynamic identification of exercise risk.
- To assess the association between health prompts delivered via wearable feedback and individual behavioral and risk changes, and explore the feasibility of active health management.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Recrutamento
- Peking University Third Hospital
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Contato:
- YiDa Tang
- Número de telefone: +86-10-82265820
- E-mail: shentao90@bjmu.edu.cn
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Contato:
- Tao Shen
- Número de telefone: +86-18201648870
- E-mail: shentao90@bjmu.edu.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Recruited from volunteers in the general population or health check-up attendees.
Descrição
Inclusion Criteria:
- Voluntarily participate in the study and sign the informed consent form; agree to continuously wear the wearable device during follow-up; able to complete scheduled follow-up visits
- Enrolled in the main cohort; having stable metabolic cardiovascular diseases (such as hypertension, type 2 diabetes mellitus (T2DM), or dyslipidemia); voluntarily sign the supplementary informed consent for the CPET substudy
Exclusion Criteria:
- Severe mental disorder or cognitive impairment, unable to understand the study content; individuals who cannot or are unsuitable to wear the device
- Presence of contraindications to CPET (e.g., uncontrolled acute coronary syndrome, acute heart failure, severe arrhythmia, etc.); functional impairment that substantially limits exercise capacity; pregnancy or lactation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
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general healthy population
This group consists of generally healthy individuals without chronic diseases such as hypertension, dyslipidemia, diabetes mellitus, coronary artery disease, and chronic obstructive pulmonary disease (COPD) |
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Participants with metabolic cardiovascular risk
The exposure factors of this group are hypertension, dyslipidemia, diabetes mellitus, coronary artery disease (CAD), heart failure (HF), and chronic obstructive pulmonary disease (COPD). All of these chronic diseases have been diagnosed in the participants. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Major Adverse Cardiovascular Events (MACE)
Prazo: From the date of baseline enrollment until the date of first MACE or censoring, assessed up to 12 months.
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Cardiovascular endpoint events: defined as major events meeting the criteria for MACE (including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), extended to other clinically significant adverse cardiovascular events such as heart failure hospitalization, unstable angina visit, and revascularization.All events will be adjudicated by at least two cardiologists based on device recordings, medical documentation and self-reported symptoms. Any disagreements will be resolved by a third-party adjudicator. |
From the date of baseline enrollment until the date of first MACE or censoring, assessed up to 12 months.
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Exercise-Related Cardiovascular Events
Prazo: From the date of baseline enrollment until the date of first exercise-related cardiovascular event or censoring, assessed up to 12 months.
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Definition of Exercise-Related Cardiovascular Events: Cardiovascular symptoms or events closely induced by exercise that occur during exercise or in the post-exercise recovery period, including but not limited to: (1) Myocardial infarction or angina attack; (2) Tachyarrhythmias: ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, paroxysmal supraventricular tachycardia occurring during exercise or recovery; (3) Bradyarrhythmias: newly developed sinus arrest, atrioventricular block, left/right bundle branch block; (4) Abnormal exercise blood pressure: systolic blood pressure ≥210 mmHg (male) or ≥190 mmHg (female) during exercise, abrupt blood pressure drop >10 mmHg with evidence of ischemia during exercise; (5) Syncope, sudden cardiac death, cardiac arrest; (6) Other cardiovascular events resulting in exercise termination. Wearable devices will be used to identify exercise episodes and analyze dynamic physiological characteristics during exercise and recov |
From the date of baseline enrollment until the date of first exercise-related cardiovascular event or censoring, assessed up to 12 months.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Doenças cardíacas
- Doença crônica
- Atributos da doença
- Doenças Metabólicas
- Doenças Respiratórias
- Doenças pulmonares
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Infarte
- Necrose
- Doenças Pulmonares Obstrutivas
- Distúrbios do metabolismo lipídico
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doença cardíaca
- Isquemia do miocárdio
- Isquemia
- Dor no peito
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Doença Pulmonar Obstrutiva Crônica
- Hipertensão
- Diabetes Mellitus, Tipo 2
- Doença arterial coronária
- Dislipidemias
- Infarto do miocárdio
- Angina Pectoris
Outros números de identificação do estudo
- M20260266
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality, in compliance with local ethical and data governance requirements.
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