- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02800421
Prognostic Impact of Organ Damage in STEMI Patients
9. juni 2016 opdateret af: Inha University Hospital
Prognostic Impact of Combined Contrast-Induced Acute Kidney Injury and Hypoxic Liver Injury in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Besides contrast-induced acute kidney injury (CI-AKI), adscititious vital organ damage such as hypoxic liver injury (HLI) may affect the survival in patients with ST-elevation myocardial infarction (STEMI).
Therefore, the investigator sought to evaluate the prognostic impact of CI-AKI and HLI in STEMI patients who underwent primary percutaneous coronary intervention (PCI).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
A total of 668 consecutive patients (77.2% male, mean age 61.3±13.3
years) with STEMI underwent primary PCI were analyzed.
Hypertension was defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, or by antihypertensive prescription.
Type 2 diabetes was defined by hypoglycemic agents or insulin prescription, fasting plasma glucose ≥126 mg/dL, glycosylated hemoglobin (HbA1c) ≥6.5%, or known but untreated hyperglycemia.
Dyslipidemia was defined by total cholesterol ≥240 mg/dL, LDL cholesterol ≥130 mg/dL, HDL cholesterol<40 mg/dL, triglycerides ≥200 mg/dL, and/or by lipid-lowering prescription.STEMI was defined as typical chest pain lasting for >30 min within the last 24h, with electrocardiographic findings of ST elevation >1 mm in at least two consecutive leads or new-onset left bundle branch block, and 2-fold elevation of serum levels of troponin-I or the creatine kinase-MB above the upper normal limit.
Obstructive CAD was defined as ≥50% luminal narrowing and the extent of obstructive CAD was categorized according to the number of vessels involved (1, 2, or 3).
CI-AKI was defined as increase in serum creatinine of ≥0.5 mg/dl or 25% relative rise, within 48h after index procedure.
HLI was defined as ≥2-fold increase of serum aspartate transaminase above upper normal limit at admission.
Patients were divided into four groups according to their CI-AKI and HLI states.
Major adverse cardiovascular and cerebrovascular events (MACCE) defined as composite of all-cause mortality, non-fatal MI, non-fatal stroke, ischemia-driven target lesion revascularization and target vessel revascularization were recorded.
Continuous data were expressed as a mean value ± standard deviation or median value (interquartile range) as appropriate.
Categorical data were presented as a percentage or absolute number.
Analyses of continuous data were performed using analysis of variance (ANOVA) test or Kruskal-Wallis test as appropriate and analyses of categorical data were performed using chi-square test to assess differences among the four groups.
Cumulative event rates as a function over time were estimated using the Kaplan-Meier method.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
668
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
30 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
A total of 668 STEMI patients (77.2% male, mean age 61.3±13.3
years) with STEMI underwent primary PCI between 2007 and 2014 were enrolled.
Primary PCI was performed according to standard clinical practice.
Pharmacological therapy, temporary pacemaker insertion, and intra-aortic balloon pump support were left to the operators' discretion.
Beskrivelse
Inclusion Criteria:
- STEMI patients who undergone primary PCI
Exclusion Criteria:
- Chronic liver disease
- Life expectancy < 1year
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 |
|---|
|
no organ damage
no evidence of HLI and CI-AKI
|
|
CI-AKI only
CI-AKI, but no HLI
|
|
HLI only
HLI, but no CI-AKI
|
|
combined CI-AKI and HLI
Both CI-AKI and HLI
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
composite major adverse cardiovascular and cerebrovascular event (MACCE)
Tidsramme: an average of 2 years
|
all-cause mortality, non-fatal MI, non-fatal stroke, and ischemia-driven TLR/TVR
|
an average of 2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Choi SH, Jang HJ, Suh YJ, Park SD, Oh PC, Moon J, Lee K, Suh J, Kang W, Kim TH, Kwon SW. Clinical Implication of Hypoxic Liver Injury for Predicting Hypoxic Hepatitis and In-Hospital Mortality in ST Elevation Myocardial Infarction Patients. Yonsei Med J. 2021 Oct;62(10):877-884. doi: 10.3349/ymj.2021.62.10.877.
- Park SD, Moon J, Kwon SW, Suh YJ, Kim TH, Jang HJ, Suh J, Park HW, Oh PC, Shin SH, Woo SI, Kim DH, Kwan J, Kang W. Prognostic Impact of Combined Contrast-Induced Acute Kidney Injury and Hypoxic Liver Injury in Patients with ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: Results from INTERSTELLAR Registry. PLoS One. 2016 Jul 14;11(7):e0159416. doi: 10.1371/journal.pone.0159416. eCollection 2016.
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
1. januar 2007
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først indsendt
6. juni 2016
Først indsendt, der opfyldte QC-kriterier
9. juni 2016
Først opslået (Skøn)
15. juni 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INHAUH 2016-05-015
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Sharing individual participant data is available, since I have full data encoded.
However, if it is feasible uploading the individual data, I would consider it positively.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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