NGAL and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction

• Conditions: No-Reflow Phenomenon; STEMI - ST Elevation Myocardial Infarction

• Registration Number: NCT03264859
• Lead Sponsor: Sheba Medical Center

Brief Summary

The aim of this study is to investigate the association between NGAL plasma levels in ST-elevation myocardial infarction and the no-reflow phenomenon, adverse events during hospitalization and at 30-day follow-up.

Detailed Description

Neutrophil Gelatinase-associated Lipocalin (NGAL) is a acute phase protein which is elevated in conditions like acute kidney injury and myocardial infarction. When a coronary artery is occluded, detrimental changes occur in myocardial vessels. After relief of the occlusion, blood flow to the heart may still be impeded, a phenomenon known as "no-reflow". Data is lacking on factors associated with early detection of patients at risk for this phenomenon, and early stratification of this group seems vital since the no-reflow phenomenon is associated with worse outcomes. The investigators hypothesized that there might be an association between higher NGAL levels and the occurrence of no-flow findings, and that NGAL might serve as a marker of worse prognosis in this population. The investigators also hypothesized that NGAL levels might serve as a marker of early acute kidney injury and that there might be specific patterns of NGAL levels over time in different subsets of patients. The aim of the study is to determine the association between NGAL levels at admission and during the first days after a ST-elevation myocardial infarction, the occurrence of the no-reflow phenomenon, the extent of myocardial damage ascertained by cardiac imaging techniques (echocardiography and cardiac resonance imaging). Data regarding patients' clinical, laboratory, electrocardiogram, coronary angiography and percutaneous coronary intervention, in-hospital and 30-day follow-up after discharge will be recorded.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-28
• Last Update Submitted: 2017-08-28
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29
• Study Start: 2017-09-15
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients > 18 years old presenting with ST-elevation myocardial infarction and undergoing urgent coronary angiography with or without PCI.
• Signed informed consent to participate in the study.

Exclusion Criteria

• Inability to sign written informed consent.
• Chronic renal failure (eGFR < 30 ml/min/1.73m2).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No-reflow phenomenon after STEMI	During hospitalization	No-reflow phenomenon as defined by electrocardiographic, angiographic and cardiac magnetic resonance imaging criteria.

Secondary Outcome Measures

Name	Time	Method
In-hospital MACE(major adverse cardiac events)	Average day 5 of hospitalization and before discharge	In-hospital MACE
The need for renal replacement therapy after STEMI	In-hospital (usually 5 days)	Patients started on hemodyalisis due to acute kidney injury during the index hospitalization
30-day MACE	30-day follow-up	30-day MACE
Serial creatinine level	On admission and at fixed time intervals (first 3 hours after admission, 12 hours, 24 hours and every 24 hours or before if indicated)	Creatinine levels as a maker of acute kidney injury reported in mg/dl
Recurrent hospitalization	30 days	Recurrent hospitalization at 30 days after the index hospitalization

Trial Locations

Locations (1)

Sheba Medical Center, Cardiac Intensive Care Unit; 🇮🇱 Ramat Gan, Israel