NCT01663194

Brief Summary

Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with adverse outcomes among patients with coronary artery disease, its role during the acute phase of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This study sought to investigate the association of the pre-procedural N/L ratio within-hospital and long-term outcomes among STEMI patients undergoing primary percutaneous coronary intervention (PCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,034

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2000

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

12.5 years

First QC Date

August 9, 2012

Last Update Submit

August 13, 2012

Conditions

Keywords

N/L ratio, STEMI, primary PCI, Long-term mortality

Study Arms (3)

N/L ratio tertile 2

patients were divided in to the tertiles

Procedure: primary percutaneous coronary intervention, each groups

N/L ratio tertile 3

patients were divided in to the tertiles

Procedure: primary percutaneous coronary intervention, each groups

N/L ratio tertile 1

patients were divided in to the tertiles

Procedure: primary percutaneous coronary intervention, each groups

Interventions

All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).

N/L ratio tertile 1N/L ratio tertile 2N/L ratio tertile 3

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

STEMI patients who were admitted within 6 hours from symptom onset and who underwent primary PCI were prospectively included in this study

You may qualify if:

  • ST elevated myocardial infarction

You may not qualify if:

  • Treatment with fibrinolytic drugs in the previous 24 hours Active infection Previously documented history of a systemic inflammatory process Known malignancy End-stage liver disease Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University school of medicine

Kayseri, 38039, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma of blood

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Mahmut Akpek, MD

    Erciyes University school of medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor of cardiology department

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

January 1, 2000

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations