- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07705997
Prospective Cohort Study of Aging in Patients With Acute Myocardial Infarction
10. juli 2026 opdateret af: The Affiliated Hospital of Hangzhou Normal University
A Single-Center, Prospective, Observational Registry Cohort Study to Investigate Aging-Related Biomarkers, Prognosis, and Risk Prediction in Patients With Acute Myocardial Infarction
This is a single-center, prospective, observational cohort study designed to investigate the association between aging-related characteristics and long-term outcomes in patients with acute myocardial infarction (AMI).
Approximately 588 eligible participants will be consecutively enrolled and followed for at least 24 months.
Clinical data, aging assessments, laboratory examinations, cardiac imaging, and blood samples will be collected to establish a clinical database and biobank.
The study aims to identify aging-related prognostic biomarkers, develop a risk prediction model integrating clinical and aging-related indicators, and improve risk stratification and individualized management for patients with AMI.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
600
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mingwei W Wang, PhD
- Telefonnummer: not 18758871517
- E-mail: wmw990556@163.com
Studiesteder
-
-
Zhejiang
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Hanzhou, Zhejiang, Kina, 310000
- MingWei Wang
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Kontakt:
- MingWei W Wang, PhD
- Telefonnummer: NOT 86-18758871517
- E-mail: wmw990556@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population includes consecutively enrolled patients with acute myocardial infarction (AMI) and aging characteristics at a single center.
Eligible participants will undergo standardized clinical assessment, aging evaluation, biospecimen collection, and prospective follow-up to investigate aging-related biomarkers and long-term clinical outcomes.
Beskrivelse
Inclusion Criteria:
- 1. Age ≥ 60 years old and meet the above comprehensive aging assessment criteria (i.e., combined with at least one clinical phenotype of aging and abnormal blood aging markers on the basis of advanced age); 2. Acute myocardial infarction occurs for ≥ 3 months; 3. Meet the diagnostic criteria for AMI in accordance with the Fourth Edition General Definition of Myocardial Infarction; 4. The patient or their legal representative signs an informed consent form.
Exclusion Criteria:
- 1. Newly diagnosed acute myocardial infarction, angina pectoris, stroke or transient ischemic attack within the past 3 months; 2. Serious life-threatening diseases (such as advanced malignant tumors, end-stage kidney disease/liver disease, severe infections) with an estimated lifespan of less than 1 year; 3. Severe cognitive impairment, mental illness, inability to cooperate in completing follow-up, aging assessment, and related examinations; 4. Unable to complete assessment items such as grip strength, walking speed, and 6-minute walk test due to non cardiac reasons such as physical disabilities and severe bone and joint diseases; 5. Failed to sign the informed consent form.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Patients With Acute Myocardial Infarction and Aging Characteristics
Patients with acute myocardial infarction (AMI) and aging characteristics who meet the eligibility criteria will be consecutively enrolled in this prospective observational cohort.
Participants will undergo comprehensive clinical evaluation, aging assessment, laboratory testing, cardiac imaging, biospecimen collection, and standardized follow-up for at least 24 months to investigate aging-related biomarkers, clinical outcomes, and prognostic risk prediction.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Major adverse cardiovascular events (MACE)
Tidsramme: Baseline through 24 months of follow-up
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The occurrence of major adverse cardiovascular events, including all-cause death, cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, stent restenosis or thrombosis, severe bleeding, and aging-related serious adverse events.
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Baseline through 24 months of follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause mortality
Tidsramme: Baseline through 24 months
|
Death from any cause during follow-up.
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Baseline through 24 months
|
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Cardiovascular mortality
Tidsramme: Baseline through 24 months
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Death attributable to cardiovascular causes, including sudden cardiac death, heart failure, or cardiogenic shock.
|
Baseline through 24 months
|
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Hospitalization for heart failure
Tidsramme: Baseline through 24 months
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Hospital admission due to worsening heart failure requiring intravenous diuretics, inotropic agents, or vasoactive therapy.
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Baseline through 24 months
|
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Recurrent myocardial infarction
Tidsramme: Baseline through 24 months
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New acute myocardial infarction occurring during follow-up according to standard diagnostic criteria.
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Baseline through 24 months
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Aging-related serious adverse events
Tidsramme: Baseline through 24 months
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Aging-related adverse outcomes, including cognitive decline, frailty-related fracture after low-energy falls, or loss of activities of daily living.
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Baseline through 24 months
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Prognostic performance of the aging-related risk prediction model
Tidsramme: At completion of the 24-month follow-up
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Predictive performance of the prognostic model integrating clinical characteristics, aging assessments, and aging-related biomarkers, evaluated using discrimination and calibration metrics.
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At completion of the 24-month follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. august 2030
Studieafslutning (Anslået)
1. september 2030
Datoer for studieregistrering
Først indsendt
10. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026(E2)-KS- 098
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