Monitoring en Rehabilitatie voor ICIACI Rehabilitatie：Een Cohortstudie
Studie naar de monitoring van kenmerken van traditionele Chinese en westerse geneeskunde en revalidatieprogramma voor ICIAM: Een cohortstudie
Immune checkpoint inhibitor-associated cardiac injury (ICIACI) is a low-incidence but highly fatal adverse event. A significant knowledge gap exists regarding the disease characteristics and recovery status of patients during the ICIACI convalescent phase. The objectives of this study are to establish a national, multicenter cohort for this patient population and to comprehensively describe their clinical profiles from an integrated Traditional Chinese and Western medicine standpoint, as well as their current rehabilitation status.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
The cohort study consists of a retrospective and a prospective cohort, enrolling eligible rehabilitation ICIACI patients from multiple centers across China. The retrospective cohort records baseline assessment data from electronic medical records and clinical sources, including demographics, cancer diagnosis and immunotherapy details, laboratory tests, electrocardiograms, imaging studies, quality of life and exercise tolerance assessments, TCM syndrome scores, and rehabilitation information, to define TCM and Western medicine clinical characteristics and rehabilitation status. The prospective cohort patients are followed up at 2, 4, and 12 weeks after enrollment, with MACE as the primary endpoint and quality of life scores as the secondary endpoint, to evaluate influencing factors of rehabilitation and its impact on prognosis.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Chengcheng Li, Dr
- Telefoonnummer: 010-84206809
- E-mail: lcc77983@126.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Under the established protocol, patients presenting with ICIACI will be enrolled from the China-Japan Friendship Hospital, Fuwai Hospital of the Chinese Academy of Medical Sciences, the Second Affiliated Hospital of Nanchang University, and Weifang Hospital of Traditional Chinese Medicine during the period from December 2025 to July 2028.
Beschrijving
Inclusion Criteria:
- Aged 18 to 80 years, inclusive
- Malignancy confirmed by cytology or histopathology
- Diagnosis of ICIACI following ICI therapy
- Assessed by the Multidisciplinary Team for Immune-Related Adverse Events as clinically recovered and entering the rehabilitation.
Exclusion Criteria:
- Diagnosis of fulminant myocarditis or cardiac function of NYHA IV
- Clear evidence suggesting cardiac injury not attributable to ICIs
- Concurrent acute cardiovascular events or malignant arrhythmias
- Coexisting severe immune-related adverse events affecting other organ systems
- Associated severe systemic diseases, such as severe hepatic or renal insufficiency, or severe infection.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: OTHER
Cohorten en interventies
Groep / Cohort |
|---|
|
ICIACI-Rehab Cohort
This observational cohort includes patients with immune checkpoint inhibitor-associated cardiac injury (ICIACI). Clinical characteristics, cardiac function, rehabilitation status, and clinical outcomes are assessed during follow-up. Rehabilitation and other treatments are provided according to routine clinical practice, without interventions assigned by the study protocol. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
MACE
Tijdsspanne: 2, 4, and 12 weeks after enrollment
|
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block |
2, 4, and 12 weeks after enrollment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Health Utility Index
Tijdsspanne: 2, 4, and 12 weeks after enrollment
|
The EQ-5D-5L assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a health utility index using the Chinese EQ-5D-5L value set, with scores ranging from -0.391 to 1.000. Higher scores indicate better health-related quality of life. Changes from baseline to Weeks 2, 4, and 12 will be assessed. |
2, 4, and 12 weeks after enrollment
|
|
Change in EuroQol Visual Analogue Scale (EQ VAS) Score
Tijdsspanne: 2, 4, and 12 weeks after enrollment
|
The EuroQol Visual Analogue Scale (EQ VAS) assesses participants' self-rated overall health status on a scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better self-rated health. Changes from baseline to Weeks 2, 4, and 12 will be assessed. |
2, 4, and 12 weeks after enrollment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jingyi Ren, Professor, China-Japan Friendship Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2023ZD0502805-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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