Relation Between NLR and IMR in STEMI Patients

• Sponsor: Inha University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02828137
• Collaborator: (none)
• Enrollment: 123
• Duration (Months): 67

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Death

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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 Start Date: May 1, 2009
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Low NLR group Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
Intermediate NLR group 1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
High NLR group Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90

Outcome Measures

Primary Outcome Measures

1. Index of Microcirculatory Resistance [3 months]

   IMR in low NLR group : 21.94 ± 12.87 IMR in intermediate NLR group : 23.22 ± 12.73 IMR in high NLR group : 32.95 ± 20.60

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Inha University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inha University Hospital
• ClinicalTrials.gov Identifier: NCT02828137
• Other Study ID Numbers: INHAUH 2016-06-012
• First Posted: Jul 11, 2016
• Last Update Posted: Aug 22, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	Low NLR Group	Intermediate NLR Group	High NLR Group
Arm/Group Description	Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78	1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90	Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
Period Title: Overall Study
STARTED	41	41	41
COMPLETED	41	41	41
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Low NLR Group	Intermediate NLR Group	High NLR Group	Total
Arm/Group Description	Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78	1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90	Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90	Total of all reporting groups
Overall Participants	41	41	41	123
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	34 82.9%	32 78%	30 73.2%	96 78%
>=65 years	7 17.1%	9 22%	11 26.8%	27 22%
Age (YEARS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [YEARS]	55 (10)	55 (11)	58 (12)	57 (12)
Sex: Female, Male (Count of Participants)
Female	6 14.6%	4 9.8%	3 7.3%	13 10.6%
Male	35 85.4%	37 90.2%	38 92.7%	110 89.4%
Region of Enrollment (participants) [Number]
Korea, Republic of	41 100%	41 100%	41 100%	123 100%

Outcome Measures

1. Primary Outcome

Title	Index of Microcirculatory Resistance
Description	IMR in low NLR group : 21.94 ± 12.87 IMR in intermediate NLR group : 23.22 ± 12.73 IMR in high NLR group : 32.95 ± 20.60
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low NLR Group	Intermediate NLR Group	High NLR Group
Arm/Group Description	Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78 IMR 21.94 ± 12.87	1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90 IMR 23.22 ± 12.73	Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90 IMR 32.95 ± 20.60
Measure Participants	41	41	41
Mean (Standard Deviation) [IMR]	21.94 (12.87)	23.22 (12.73)	32.95 (20.60)

Adverse Events

Arm/Group Title	Low NLR Group		Intermediate NLR Group		High NLR Group
Arm/Group Description	Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78		1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90		Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
All Cause Mortality
	Low NLR Group		Intermediate NLR Group		High NLR Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Low NLR Group		Intermediate NLR Group		High NLR Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Low NLR Group		Intermediate NLR Group		High NLR Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.