Prognostic Impact of Organ Damage in STEMI Patients

NCT02800421 | Completed DMC

• 1 other identifier: INHAUH 2016-05-015
• Study Type: observational
• Target: 668
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Myocardial Infarction; Death; Acute Kidney Injury; Hepatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• STEMI patients who undergone primary PCI

You may not qualify if:

• Chronic liver disease
• Life expectancy \< 1year

Sponsors & Collaborators

• Inha University Hospital: lead

Related Publications (2)

• 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.

  PMID: 34558866 DERIVED

• 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.

  PMID: 27415006 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Death; Acute Kidney Injury; Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 15, 2016
• Study Start: January 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: June 15, 2016

Record last verified: 2016-06