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

NCT03264859 | Unknown

• 1 other identifier: SHEBA-17-4157-SM-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

No-Reflow Phenomenon; STEMI - ST Elevation Myocardial Infarction

Keywords

NGAL; STEMI; no-reflow; PCI (Percutaneous Coronary Intervention)

Outcome Measures

Primary Outcomes (1)

• No-reflow phenomenon after STEMI

  No-reflow phenomenon as defined by electrocardiographic, angiographic and cardiac magnetic resonance imaging criteria.

  During hospitalization

Secondary Outcomes (5)

• In-hospital MACE(major adverse cardiac events)

  Average day 5 of hospitalization and before discharge

• 30-day MACE

  30-day follow-up

• 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)

• The need for renal replacement therapy after STEMI

  In-hospital (usually 5 days)

• Recurrent hospitalization

  30 days

Interventions

NGAL levels early and post STEMI DIAGNOSTIC_TEST

NGAL levels early and post ST elevation MI (STEMI)

Eligibility Criteria

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

Study Population

Patients admitted to the Sheba Medical Center

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Zotal Inc.: collaborator

Study Sites (1)

Sheba Medical Center, Cardiac Intensive Care Unit

Ramat Gan, Israel

Location

Related Publications (13)

• 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.

  PMID: 7683678 BACKGROUND

• 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.

  PMID: 7997842 BACKGROUND

• 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.

  PMID: 15811456 BACKGROUND

• 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.

  PMID: 17827339 BACKGROUND

• 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.

  PMID: 19766756 BACKGROUND

• 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.

  PMID: 16931980 BACKGROUND

• 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.

  PMID: 16772710 BACKGROUND

• 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.

  PMID: 27275154 BACKGROUND

• 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.

  PMID: 11028471 BACKGROUND

• 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.

  PMID: 24801557 BACKGROUND

• 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.

  PMID: 26438132 BACKGROUND

• 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.

  PMID: 22222228 BACKGROUND

• 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.

  PMID: 28592591 BACKGROUND

MeSH Terms

Conditions

No-Reflow Phenomenon; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Necrosis

Study Officials

• Shlomi Matetzky, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Chernomordik, M.D.

CONTACT

+972-3-5302504; fernando.chernomordik@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Intensive Care Care Unit

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 29, 2017
• Study Start: September 15, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)