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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Rekrutierung
- Peking University Third Hospital
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Kontakt:
- YiDa Tang
- Telefonnummer: +86-10-82265820
- E-Mail: shentao90@bjmu.edu.cn
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Kontakt:
- Tao Shen
- Telefonnummer: +86-18201648870
- E-Mail: shentao90@bjmu.edu.cn
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Recruited from volunteers in the general population or health check-up attendees.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Major Adverse Cardiovascular Events (MACE)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des endokrinen Systems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Herzkrankheiten
- Chronische Erkrankung
- Krankheitsattribute
- Stoffwechselerkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Störungen des Glukosestoffwechsels
- Diabetes Mellitus
- Infarkt
- Nekrose
- Lungenerkrankungen, obstruktive
- Störungen des Fettstoffwechsels
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Koronare Krankheit
- Myokardischämie
- Ischämie
- Brustschmerzen
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Lungenerkrankung, chronisch obstruktiv
- Hypertonie
- Diabetes mellitus, Typ 2
- Koronare Herzkrankheit
- Dyslipidämien
- Herzinfarkt
- Angina pectoris
Andere Studien-ID-Nummern
- M20260266
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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