Relation Between NLR and IMR in STEMI Patients

Myocardial Infarction Clinical Trial

Official title:

Relationships Between Neutrophil-to-Lymphocyte Ratio and Index of Microcirculatory Resistance in ST-segment Elevation Myocardial Infarction Patients Undergone Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828137
• Other study ID #: INHAUH 2016-06-012
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: July 8, 2016
• Start date: May 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2016
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The neutrophil-to-lymphocyte ratio (NLR) has been proven to be reliable inflammatory marker for atherosclerotic process and predictor for clinical outcomes in patients with various cardiovascular diseases. Recent study reported elevated NLR was associated with impaired myocardial perfusion in ST-segment elevation myocardial infarction (STEMI) patients. The investigators sought to determine whether NLR is associated with coronary microcirculation assessed by index of microcirculatory resistance (IMR) in STEMI patients who undergone primary percutaneous coronary intervention (PCI). A total of 123 patients with STEMI underwent successful primary PCI were consecutively enrolled. NLR at admission was calculated, and the patients were divided into three groups according to NLR tertiles. IMR was measured by intracoronary thermodilution-derived method immediately after index PCI.

Description:

A total of 123 consecutive STEMI patients who underwent successful primary PCI and coronary physiologic study immediately after PCI were retrospectively enrolled in the study. All patients underwent index PCI between May 2009 and October 2014 at INHA university hospital. The definition of STEMI was determined by the current guidelines.

Complete blood counts, including total and differential WBC counts, were obtained at the time of admission. Total counts of WBC, neutrophils, and lymphocytes were assessed using an automated blood cell counter (XE-2100, Sysmex Inc., Japan). NLR was calculated as the ratio of the neutrophil counts to the lymphocyte counts. All patients were divided into 3 groups according to the NLR tertiles.

The IMR was assessed shortly after primary PCI by using thermodilution-derived method. After successful interventional reperfusion, intracoronary nitroglycerin (100~200μg) was administered and coronary pressure guidewire (Radi Pressure Wire 5, Radi Medical Systems, Uppsala, Sweden) was calibrated outside the patient. The guidewire was equalized at the distal tip of guiding catheter, and then advanced towards the distal third of infarct related artery (IRA). Three times of saline injection (3~5 ml) were administered to IRA and baseline mean transit time was assessed. Microcirculatory hyperemia was induced by using an adenosine infusion (140 μg/kg.min) administered via peripheral venous line. During maximal hyperemia, hyperemic mean transit time (Tmn) was measured using same method as prior separate saline injections. Mean aortic (Pa) and distal coronary pressures (Pd) was measured during hyperemia. The IMR was calculated the formula as follows: IMR = Pd x hyperemic Tmn. Fractional flow reserve (FFR) was calculated by ratio of Pd to Pa during maximal hyperemic status. Coronary flow reserve (CFR) was derived from dividing the resting Tmn by hyperemic Tmn.

Continuous variables were presented as mean ± standard deviation (SD) and categorical variables as the number of patients (percentages). The one way analysis of variance (ANOVA) was used for comparing continuous variables. Additionally, post-hoc analysis was performed for evaluating to be significant by ANOVA. The Pearson's chi-square test or Fisher's exact test was used for analyzing categorical variables. Linear regression analysis was performed for investigating the association between NLR and variables using clinical, laboratory, echocardiographic, and angiographic data. A p value <0.05 was regarded statistically significant. All statistical analyses were carried out with SPSS version 19.0 (SPSS inc., Chicago, Illinois, USA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• STEMI patients who undergone primary PCI

Exclusion Criteria:

• unprotected left main coronary artery disease

• stent thrombosis presentation

• a history of coronary artery bypass graft surgery

• prior intravenous thrombolytic therapy before PCI

• high degree atrioventricular block

• remained cardiogenic shock after complete PCI

• contraindication for use of adenosine

• post-PCI thrombolysis in myocardial infarction (TIMI) flow grade 0 or 1

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Death
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of Microcirculatory Resistance		3 months	No