NCT02828137

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1 month until next milestone

Results Posted

Study results publicly available

August 22, 2016

Completed
Last Updated

August 22, 2016

Status Verified

June 1, 2016

Enrollment Period

5.4 years

First QC Date

June 30, 2016

Results QC Date

July 9, 2016

Last Update Submit

July 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Index of Microcirculatory Resistance

    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

    3 months

Study Arms (3)

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

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • STEMI patients who undergone primary PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myocardial InfarctionDeath

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Dr. Sung Woo Kwon
Organization
Inha University Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

May 1, 2009

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

August 22, 2016

Results First Posted

August 22, 2016

Record last verified: 2016-06