Prognostic Impact of Organ Damage in STEMI Patients

Sponsor
Inha University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02800421
Collaborator
(none)
668
101.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    668 participants
    Observational Model:
    Cohort
    Official Title:
    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
    Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Jul 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. composite major adverse cardiovascular and cerebrovascular event (MACCE) [an average of 2 years]

      all-cause mortality, non-fatal MI, non-fatal stroke, and ischemia-driven TLR/TVR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • STEMI patients who undergone primary PCI
    Exclusion Criteria:
    • Chronic liver disease

    • Life expectancy < 1year

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Inha University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inha University Hospital
    ClinicalTrials.gov Identifier:
    NCT02800421
    Other Study ID Numbers:
    • INHAUH 2016-05-015
    First Posted:
    Jun 15, 2016
    Last Update Posted:
    Jun 15, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2016