- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264859
NGAL and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction
August 28, 2017 updated by: Dr. Shlomi Matetzky, Sheba Medical Center
Neutrophil Gelatinase-associated Lipocalin (NGAL) and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fernando Chernomordik, M.D.
- Phone Number: +972-3-5302504
- Email: fernando.chernomordik@sheba.health.gov.il
Study Locations
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Ramat Gan, Israel
- Sheba Medical Center, Cardiac Intensive Care Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the Sheba Medical Center
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
No-reflow phenomenon after STEMI
Time Frame: During hospitalization
|
No-reflow phenomenon as defined by electrocardiographic, angiographic and cardiac magnetic resonance imaging criteria.
|
During hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-hospital MACE(major adverse cardiac events)
Time Frame: Average day 5 of hospitalization and before discharge
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In-hospital MACE
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Average day 5 of hospitalization and before discharge
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30-day MACE
Time Frame: 30-day follow-up
|
30-day MACE
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30-day follow-up
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Serial creatinine level
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)
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Creatinine levels as a maker of acute kidney injury reported in mg/dl
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On admission and at fixed time intervals (first 3 hours after admission, 12 hours, 24 hours and every 24 hours or before if indicated)
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The need for renal replacement therapy after STEMI
Time Frame: In-hospital (usually 5 days)
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Patients started on hemodyalisis due to acute kidney injury during the index hospitalization
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In-hospital (usually 5 days)
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Recurrent hospitalization
Time Frame: 30 days
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Recurrent hospitalization at 30 days after the index hospitalization
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shlomi Matetzky, Prof., Sheba Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kjeldsen L, Johnsen AH, Sengelov H, Borregaard N. Isolation and primary structure of NGAL, a novel protein associated with human neutrophil gelatinase. J Biol Chem. 1993 May 15;268(14):10425-32.
- Xu SY, Carlson M, Engstrom A, Garcia R, Peterson CG, Venge P. Purification and characterization of a human neutrophil lipocalin (HNL) from the secondary granules of human neutrophils. Scand J Clin Lab Invest. 1994 Aug;54(5):365-76. doi: 10.3109/00365519409088436.
- Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X.
- Leclercq A, Houard X, Philippe M, Ollivier V, Sebbag U, Meilhac O, Michel JB. Involvement of intraplaque hemorrhage in atherothrombosis evolution via neutrophil protease enrichment. J Leukoc Biol. 2007 Dec;82(6):1420-9. doi: 10.1189/jlb.1106671. Epub 2007 Sep 7.
- Zografos T, Haliassos A, Korovesis S, Giazitzoglou E, Voridis E, Katritsis D. Association of neutrophil gelatinase-associated lipocalin with the severity of coronary artery disease. Am J Cardiol. 2009 Oct 1;104(7):917-20. doi: 10.1016/j.amjcard.2009.05.023.
- Wagener G, Jan M, Kim M, Mori K, Barasch JM, Sladen RN, Lee HT. Association between increases in urinary neutrophil gelatinase-associated lipocalin and acute renal dysfunction after adult cardiac surgery. Anesthesiology. 2006 Sep;105(3):485-91. doi: 10.1097/00000542-200609000-00011.
- Bachorzewska-Gajewska H, Malyszko J, Sitniewska E, Malyszko JS, Dobrzycki S. Neutrophil-gelatinase-associated lipocalin and renal function after percutaneous coronary interventions. Am J Nephrol. 2006;26(3):287-92. doi: 10.1159/000093961. Epub 2006 Jun 13.
- Lindberg S, Jensen JS, Hoffmann S, Iversen AZ, Pedersen SH, Biering-Sorensen T, Galatius S, Flyvbjerg A, Mogelvang R, Magnusson NE. Plasma Neutrophil Gelatinase-Associated Lipocalin Reflects Both Inflammation and Kidney Function in Patients with Myocardial Infarction. Cardiorenal Med. 2016 May;6(3):180-90. doi: 10.1159/000443846. Epub 2016 Feb 25.
- Morishima I, Sone T, Okumura K, Tsuboi H, Kondo J, Mukawa H, Matsui H, Toki Y, Ito T, Hayakawa T. Angiographic no-reflow phenomenon as a predictor of adverse long-term outcome in patients treated with percutaneous transluminal coronary angioplasty for first acute myocardial infarction. J Am Coll Cardiol. 2000 Oct;36(4):1202-9. doi: 10.1016/s0735-1097(00)00865-2.
- Aksan G, Soylu K, Aksoy O, Ozdemir M, Yanik A, Yuksel S, Gedikli O, Gulel O, Sahin M. The relationship between neutrophil gelatinase-associated lipocalin levels and the slow coronary flow phenomenon. Coron Artery Dis. 2014 Sep;25(6):505-9. doi: 10.1097/MCA.0000000000000121.
- Helanova K, Littnerova S, Kubena P, Ganovska E, Pavlusova M, Kubkova L, Jarkovsky J, Pavkova Goldbergova M, Lipkova J, Gottwaldova J, Kala P, Toman O, Dastych M, Spinar J, Parenica J. Prognostic impact of neutrophil gelatinase-associated lipocalin and B-type natriuretic in patients with ST-elevation myocardial infarction treated by primary PCI: a prospective observational cohort study. BMJ Open. 2015 Oct 5;5(10):e006872. doi: 10.1136/bmjopen-2014-006872.
- Akcay AB, Ozlu MF, Sen N, Cay S, Ozturk OH, Yalcn F, Bilen P, Kanat S, Karakas MF, Isleyen A, Demir AD, Sogut S, Covic A, Kanbay M. Prognostic significance of neutrophil gelatinase-associated lipocalin in ST-segment elevation myocardial infarction. J Investig Med. 2012 Feb;60(2):508-13. doi: 10.2310/JIM.0b013e31823e9d86.
- Durante A, Laricchia A, Benedetti G, Esposito A, Margonato A, Rimoldi O, De Cobelli F, Colombo A, Camici PG. Identification of High-Risk Patients After ST-Segment-Elevation Myocardial Infarction: Comparison Between Angiographic and Magnetic Resonance Parameters. Circ Cardiovasc Imaging. 2017 Jun;10(6):e005841. doi: 10.1161/CIRCIMAGING.116.005841.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 15, 2017
Primary Completion (Anticipated)
October 31, 2018
Study Completion (Anticipated)
October 31, 2018
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 28, 2017
First Posted (Actual)
August 29, 2017
Study Record Updates
Last Update Posted (Actual)
August 29, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-17-4157-SM-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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