Myocardial InfarctionNCT02828137
Relation Between NLR and IMR in STEMI Patients
An observational study of Myocardial Infarction and Death, run by Inha University Hospital.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Myocardial Infarction, Death
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- STEMI patients who undergone primary PCI
Who cannot join
- 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
About this study
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
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.
Read the 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).
- Conditions
- Myocardial Infarction, Death
- Medical subject headings
- Myocardial Infarction, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMay 2009
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828137
- Sponsor's protocol ID
- INHAUH 2016-06-012
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 22 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: If it is feasible to upload the individual data, the investigator would consider it positively.
Publications
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.
PubMed 27600462
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02828137
- Acronym / sponsor ID
- INHAUH 2016-06-012
- Conditions
- Myocardial Infarction, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 22 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- STEMI patients who undergone primary PCI
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Index of Microcirculatory Resistance
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27600462Lee 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.
- Individual participant dataSharing planned: Undecided. If it is feasible to upload the individual data, the investigator would consider it positively.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Death, run by Inha University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of Microcirculatory Resistance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.