No-Reflow Phenomenon, STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
NGAL, STEMI, no-reflow, PCI (Percutaneous Coronary Intervention)
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.
Interventions
DIAGNOSTIC_TESTNGAL levels early and post STEMI
NGAL levels early and post ST elevation MI (STEMI)
Sponsors
Zotal Inc.
Sheba Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No-reflow phenomenon after STEMI | During hospitalization | No-reflow phenomenon as defined by electrocardiographic, angiographic and cardiac magnetic resonance imaging criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent hospitalization | 30 days | Recurrent hospitalization at 30 days after the index hospitalization |
| In-hospital MACE(major adverse cardiac events) | Average day 5 of hospitalization and before discharge | In-hospital MACE |
| 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 |
| 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 |
Countries
Israel
Contacts
Primary ContactFernando Chernomordik, M.D.
Outcome results
None listed