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

NCT ID: NCT03264859

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2018-10-31

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.

Conditions

No-Reflow Phenomenon; STEMI - ST Elevation Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

NGAL levels early and post STEMI

NGAL levels early and post ST elevation MI (STEMI)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zotal Inc.

UNKNOWN

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Shlomi Matetzky

Head, Intensive Care Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shlomi Matetzky, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center, Cardiac Intensive Care Unit

Ramat Gan, , Israel

Countries

Israel

Central Contacts

Fernando Chernomordik, M.D.

Role: CONTACT

fernando.chernomordik@sheba.health.gov.il

+972-3-5302504

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Other Identifiers

SHEBA-17-4157-SM-CTIL

Identifier Type: -

Identifier Source: org_study_id