Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahmut Akpek, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01663194
First received: August 9, 2012
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with adverse outcomes among patients with coronary artery disease, its role during the acute phase of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This study sought to investigate the association of the pre-procedural N/L ratio within-hospital and long-term outcomes among STEMI patients undergoing primary percutaneous coronary intervention (PCI).


Condition Intervention
ST Elevated Myocardial Infarction
Procedure: primary percutaneous coronary intervention, each groups

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of N/L Ratio in Patients With STEMI

Resource links provided by NLM:


Further study details as provided by TC Erciyes University:

Biospecimen Retention:   Samples Without DNA

serum and plasma of blood


Enrollment: 1034
Study Start Date: January 2000
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
N/L ratio tertile 2
patients were divided in to the tertiles
Procedure: primary percutaneous coronary intervention, each groups
All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).
N/L ratio tertile 3
patients were divided in to the tertiles
Procedure: primary percutaneous coronary intervention, each groups
All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).
N/L ratio tertile 1
patients were divided in to the tertiles
Procedure: primary percutaneous coronary intervention, each groups
All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).

Detailed Description:

Inflammation plays a role in the initiation and progression of the atherosclerotic process. Due to a growing recognition of its role, recent studies have focused on inflammatory markers and their association with outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Recently, our single center study demonstrated that preprocedural neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L ratio in long-term outcomes among patients with STEMI; however, they evaluated the association between long-term mortality and in-hospital N/L ratio, they were single-center studies and they evaluated a relatively small study population.

In the present multicenter experience, the investigators aimed to investigate the association of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with STEMI undergoing primary PCI.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

STEMI patients who were admitted within 6 hours from symptom onset and who underwent primary PCI were prospectively included in this study

Criteria

Inclusion Criteria:

ST elevated myocardial infarction

Exclusion Criteria:

Treatment with fibrinolytic drugs in the previous 24 hours Active infection Previously documented history of a systemic inflammatory process Known malignancy End-stage liver disease Renal failure

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663194

Locations
Turkey
Erciyes University school of medicine
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Study Director: Mahmut Akpek, MD Erciyes University school of medicine
  More Information

No publications provided

Responsible Party: Mahmut Akpek, Medical doctor of cardiology department, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01663194     History of Changes
Other Study ID Numbers: mgkaya-makpek
Study First Received: August 9, 2012
Last Updated: August 13, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by TC Erciyes University:
N/L ratio, STEMI, primary PCI, Long-term mortality

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014