Prognostic Impact of Organ Damage in STEMI Patients

Completed

• Conditions: Acute Kidney Injury; Death; Myocardial Infarction; Hepatic Insufficiency

• Registration Number: NCT02800421
• Lead Sponsor: Inha University Hospital

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).

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Status Verified: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

• STEMI patients who undergone primary PCI

Read More

Exclusion Criteria

• Chronic liver disease
• Life expectancy < 1year

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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