Prognostic Impact of Organ Damage in STEMI Patients

NCT ID: NCT02800421

Last Updated: 2016-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 668 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Myocardial Infarction; Death; Acute Kidney Injury; Hepatic Insufficiency

Study Design

• Observational Model Type: COHORT

Study Groups

no organ damage

no evidence of HLI and CI-AKI

No interventions assigned to this group

CI-AKI only

CI-AKI, but no HLI

No interventions assigned to this group

HLI only

HLI, but no CI-AKI

No interventions assigned to this group

combined CI-AKI and HLI

Both CI-AKI and HLI

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• STEMI patients who undergone primary PCI

Exclusion Criteria

• Chronic liver disease
• Life expectancy < 1year

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inha University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 34558866 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27415006 (View on PubMed)

Other Identifiers

INHAUH 2016-05-015

Identifier Type: -

Identifier Source: org_study_id