ST Elevated Myocardial InfarctionNCT01663194
Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction
An observational study of ST Elevated Myocardial Infarction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ST Elevated Myocardial Infarction
- What is being tested?
- primary percutaneous coronary intervention, each groups
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,034 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2000to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STEMI patients who were admitted within 6 hours from symptom onset and who underwent primary PCI were prospectively included in this study
Who may be able to join
- ST elevated myocardial infarction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University school of medicine
Kayseri, 38039
About this study
Official title: Observational Study of N/L Ratio in Patients With STEMI
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).
Read the detailed description
Inflammation plays a role in the initiation and progression of the atherosclerotic process. Due to a growing recognition of its role, recent studies have focused on inflammatory markers and their association with outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Recently, our single center study demonstrated that preprocedural neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L ratio in long-term outcomes among patients with STEMI; however, they evaluated the association between long-term mortality and in-hospital N/L ratio, they were single-center studies and they evaluated a relatively small study population.
In the present multicenter experience, the investigators aimed to investigate the association of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with STEMI undergoing primary PCI.
- Conditions
- ST Elevated Myocardial Infarction
- Being tested
- primary percutaneous coronary intervention, each groups
- Keywords
- N/L ratio, STEMI, primary PCI, Long-term mortality
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary percutaneous coronary intervention, each groupsProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| N/L ratio tertile 2 | patients were divided in to the tertiles Receives: Procedure: primary percutaneous coronary intervention, each groups | |
| N/L ratio tertile 3 | patients were divided in to the tertiles Receives: Procedure: primary percutaneous coronary intervention, each groups | |
| N/L ratio tertile 1 | patients were divided in to the tertiles Receives: Procedure: primary percutaneous coronary intervention, each groups |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startJan 2000
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Akpek, TC Erciyes University
- Investigators
- Mahmut Akpek, MD, Study director, Erciyes University school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663194
- Sponsor's protocol ID
- mgkaya-makpek
- Status last verified
- Aug 2012
- First submitted
- 9 Aug 2012
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of N/L Ratio in Patients With STEMI
- ClinicalTrials.gov ID
- NCT01663194
- Acronym / sponsor ID
- mgkaya-makpek
- Conditions
- ST Elevated Myocardial Infarction
- Keywords
- N/L ratio, STEMI, primary PCI, Long-term mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Inflammation plays a role in the initiation and progression of the atherosclerotic process. Due to a growing recognition of its role, recent studies have focused on inflammatory markers and their association with outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Recently, our single center study demonstrated that preprocedural neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L ratio in long-term outcomes among patients with STEMI; however, they evaluated the association between long-term mortality and in-hospital N/L ratio, they were single-center studies and they evaluated a relatively small study population.
In the present multicenter experience, the investigators aimed to investigate the association of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with STEMI undergoing primary PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N/L ratio tertile 2 | – | Procedure: primary percutaneous coronary intervention, each groupspatients were divided in to the tertiles |
| N/L ratio tertile 3 | – | Procedure: primary percutaneous coronary intervention, each groupspatients were divided in to the tertiles |
| N/L ratio tertile 1 | – | Procedure: primary percutaneous coronary intervention, each groupspatients were divided in to the tertiles |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients who were admitted within 6 hours from symptom onset and who underwent primary PCI were prospectively included in this study
Key inclusion criteria (1 listed)
- ST elevated myocardial infarction
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary percutaneous coronary intervention, each groupsAll 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). | Procedure or surgery | N/L ratio tertile 1, N/L ratio tertile 2, N/L ratio tertile 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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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.
Mahmut Akpek, MD study director
Erciyes University school of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevated Myocardial Infarction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 1 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 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 14 Aug 2012.