Prognostic Impact of Organ Damage in STEMI Patients

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800421
• Other study ID #: INHAUH 2016-05-015
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 9, 2016
• Start date: January 2007
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 668
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• STEMI patients who undergone primary PCI

Exclusion Criteria:

• Chronic liver disease

• Life expectancy < 1year

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Acute Kidney Injury
• Death
• Hepatic Insufficiency
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite major adverse cardiovascular and cerebrovascular event (MACCE)	all-cause mortality, non-fatal MI, non-fatal stroke, and ischemia-driven TLR/TVR	an average of 2 years	No