- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04935086
Risk Factors for Predictors of MACEs After RA-CABG
Risk Factors for Predictors of Major Adverse Cardiovascular Events After Coronary Artery Bypass Using Radial Artery Grafts
As the secondary choice of artery grafts, radial artery is more and more used to achieve multiple arterial revascularization in CABG. Risk factors for predictors of major cardiovascular adverse events (MACE) after CABG using radial-artery grafts (RA-CABG), however, remain uncertain. This case-control study aims to identify the baseline predictors of MACE after RA-CABG.
We will collect the baseline characteristics and perioperative data of patients underwent RA-CABG from Jan. 2009 to Dec. 2019 in our single center. By reviewing the latest follow-up records, we will examine the correlation between the baseline characteristics and clinical outcomes (MACEs), then identify the independent risk factors for predictors of MACEs after RA-CABG.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Shanghai
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Shanghai, Shanghai, Kina, 200025
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Underwent CABG using at least a radial artery grafts from Jan.2009 to Dec.2019. with or without cardiopulmonary bypass , with or without concomitant procedure
- Aged 18 and above at procedure
- With any gender
Exclusion Criteria:
- With unavailable medical records
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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MACE Group
MACE Group includes the patients suffered from any component of MACE after RA-CABG until the latest follow-up.
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Non-MACE Group
Non-MACE Group includes the patients freed from any component of MACE after RA-CABG until the latest follow-up.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
7-day MACE-4
Tidsramme: 7 days post-CABG
|
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
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7 days post-CABG
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30-day MACE-4
Tidsramme: 30 days post-CABG
|
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
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30 days post-CABG
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1-year MACE-4
Tidsramme: 1 year post-CABG
|
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
|
1 year post-CABG
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3-year MACE-4
Tidsramme: 3 years post-CABG
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a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
|
3 years post-CABG
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
MACE-3
Tidsramme: 7 days, 30 days, 1 year, and 3 years post-CABG
|
a composite of CV-death, myocardial infraction and stroke
|
7 days, 30 days, 1 year, and 3 years post-CABG
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All-cause death
Tidsramme: 7 days, 30 days, 1 year, and 3 years post-CABG
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Death from any cause
|
7 days, 30 days, 1 year, and 3 years post-CABG
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CV-death
Tidsramme: 7 days, 30 days, 1 year, and 3 years post-CABG
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Including death resulting from an acute myocardial infarction , sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, and death due to other cardiovascular causes
|
7 days, 30 days, 1 year, and 3 years post-CABG
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Myocardial infraction
Tidsramme: 7 days, 30 days, 1 year, and 3 years post-CABG
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According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including CABG-related MI, non CABG-related MI, silent MI and unknown type.
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7 days, 30 days, 1 year, and 3 years post-CABG
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Stroke
Tidsramme: 7 days, 30 days, 1 year, and 3 years post-CABG
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According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including ischemic, hemorrhagic and unknown type.
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7 days, 30 days, 1 year, and 3 years post-CABG
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Repeat revascularization
Tidsramme: 7 days, 30 days, 1 year, and 3 years post-CABG
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According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including any PCI and CABG.
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7 days, 30 days, 1 year, and 3 years post-CABG
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Yunpeng Zhu, MD, Ruijin Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KY-2020388
Plan for individuelle deltakerdata (IPD)
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