Clinical trial NCT02828137: Relation Between NLR and IMR in STEMI Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Death
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 123
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Index of Microcirculatory Resistance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lee MJ, Park SD, Kwon SW, Woo SI, Lee MD, Shin SH, Kim DH, Kwan J, Park KS. Relation Between Neutrophil-to-Lymphocyte Ratio and Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Am J Cardiol. 2016 Nov 1;118(9):1323-1328. doi: 10.1016/j.amjcard.2016.07.072. Epub 2016 Aug 13.