An observational study in No-Reflow Phenomenon and STEMI - ST Elevation Myocardial Infarction, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Sheba Medical Center · Observational
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.
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.
27 studies on the registry are indexed under No-Reflow Phenomenon; 9 are open to participants now.
Browse No-Reflow Phenomenon studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
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Patients admitted to the Sheba Medical Center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NGAL levels early and post ST elevation MI (STEMI)
No-reflow phenomenon after STEMI
No-reflow phenomenon as defined by electrocardiographic, angiographic and cardiac magnetic resonance imaging criteria.
Time frame: During hospitalization
In-hospital MACE(major adverse cardiac events)
In-hospital MACE
Time frame: Average day 5 of hospitalization and before discharge
30-day MACE
30-day MACE
Time frame: 30-day follow-up
Serial creatinine level
Creatinine levels as a maker of acute kidney injury reported in mg/dl
Time frame: On admission and at fixed time intervals (first 3 hours after admission, 12 hours, 24 hours and every 24 hours or before if indicated)
The need for renal replacement therapy after STEMI
Patients started on hemodyalisis due to acute kidney injury during the index hospitalization
Time frame: In-hospital (usually 5 days)
Recurrent hospitalization
Recurrent hospitalization at 30 days after the index hospitalization
Time frame: 30 days
Plan to share: No
Start is estimated for Sep 2017; primary completion for Oct 2018, 13 months later.
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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