Myocard Infarctusnon-STEMINCT04763213
New Predictors in Determining the Need for Invasive Treatment in Non-STEMI
An observational study of Myocard Infarctus, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocard Infarctus
- What is being tested?
- Coronary Angiography
- How many people
- 276 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between January 2018 and December 2019, patients admitted to the Cardiology clinic of a tertiary care hospital with a diagnosis of NSTEMI-ACS were evaluated consecutively
Who may be able to join
- NonST elevated myocard ınfarctus
- Elder than 18 years
- Patients who were not have the exclusion criterias
Who cannot join
- Under the age of 18,
- Recurrent or ongoing chest pain resistant to drug therapy,
- Hemodynamic instability,
- Life-threatening ventricular arrhythmias or cardiac arrest,
- Development of mechanical complications and the presence of dynamic ST-T wave changes (intermittent ST-segment elevation),
- Heart failure,
Show all 21Show fewer
- Ejection fraction <40,
- Severe anemia,
- Sepsis,
- Malignancy,
- Chronic hematological disease,
- Collagen tissue disease
- Obesity,
- Moderate to severe hepatic failure,
- Renal failure (Glomerular filtration rate <60 ml/min/1.73 m2),
- Severe valvular heart disease,
- Electrolyte disturbance,
- Chronic anti-inflammatory drug use,
- History of chronic inflammatory disease,
- A history of serious infection in the last month
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Predictors in Determining the Need for Invasive Treatment in Non-STEMI During the COVID-19 Pandemic: A Retrospective Study
Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Non-ST elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) is one of the subcomponents of NSTE-ACS, which has an increased mortality rate, and for which early intervention can be vital. Yet, most of these patients require invasive treatment. In fact, some of them are patients who require very early invasive treatment and have a complete occlusion in the culprit artery. Unfortunately, risk scoring systems are not sufficient enough to differentiate these patients. Therefore, the discovery of markers that can be used in the differentiation of NSTEMI-ACS patients with an increased need for invasive treatment and/or complete occlusion of the culprit's vessels, especially during pandemic periods such as the COVID-19 pandemic, has gained importance.
Inflammation is known to play an important role in the etiopathogenesis of coronary artery disease. To the best of our knowledge, there is a lack of literature on the relationship between the need for invasive treatment strategy and/or complete occlusion of the culprit's vessel, and the hematological markers in patients diagnosed with NSTEMI-ACS.
Read the detailed description
Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Non-ST elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) is one of the subcomponents of NSTE-ACS, which has an increased mortality rate, and for which early intervention can be vital. In the European Society of Cardiology (ESC) guidelines, NSTEMI-ACS is defined as a high-risk condition that requires diagnostic angiography within 2 hours at the latest in those with very high-risk criteria and within 24 hours at the latest in those who do not have high risk. However, the non-invasive approach has come to the fore for the NSTEMI-ACS disease due to the COVID-19 pandemic conditions. In the recently published national consensus report, during the COVID-19 pandemic period, medium-high risk NSTEMI-ACS patients are recommended optimal medical therapy as an alternative treatment method, even if the diagnosis of COVID-19 was excluded, especially in areas where pandemic effects are being experienced intensely. Yet, most of these patients require invasive treatment. In fact, some of them are patients who require very early invasive treatment and have a complete occlusion in the culprit artery. Unfortunately, risk scoring systems are not sufficient enough to differentiate these patients. Therefore, the discovery of markers that can be used in the differentiation of NSTEMI-ACS patients with an increased need for invasive treatment and/or complete occlusion of the culprit's vessels, especially during pandemic periods such as the COVID-19 pandemic, has gained importance.
Inflammation is known to play an important role in the etiopathogenesis of coronary artery disease. In recent years, it has been shown that hematological parameters closely associated with inflammation in people with coronary artery disease may be useful in distinguishing those with increased severity of atherosclerotic involvement and those with high mortality risk. The main markers used in studies are Leukocyte count, neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte Ratio (PLR), systemic immune inflammation index (SII), red blood cell distribution width (RDW), and mean platelet volume (MPV). To the best of our knowledge, there is a lack of literature on the relationship between the need for invasive treatment strategy and/or complete occlusion of the culprit's vessel, and the hematological markers in patients diagnosed with NSTEMI-ACS.
- Conditions
- Myocard Infarctus
- Being tested
- Coronary Angiography
- Keywords
- Non-ST elevation myocardial infarction acute coronary syndrome, Neutrophil-lymphocyte ratio, Systemic immune inflammation index, Invasive treatment strategy, Conservative strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyDiagnostic test
Also called Invasive treatment
Patients diagnosed with occlusive or nonocclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting)
Coronary AngiographyDiagnostic test
Also called Medical treatment
Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically
| Study group | Role | What they receive |
|---|---|---|
| Invasive treatment | Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting) Receives: Diagnostic Test: Coronary Angiography | |
| Medically treatment | Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically Receives: Diagnostic Test: Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors for Non ST elevated MI Blood prarameters Predictive factors for Non ST eleveted MI
The relationship between inflammation markers such as red cell distribution width (%), mean platelet volume (fL), Systemic immune-inflammation index (platelet count (10^9/L)x neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), neutrophil to lymphocyte ratio (neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), platelet to lymphocyte ratio (neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), and treatment strategy in patients diagnosed with Non-ST myocardial infarction was investigated.
Measured: Pretreatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Myocard InfarctusStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekrem Aksu, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763213
- Sponsor's protocol ID
- 05.08.2020-2020/15/10
- Acronym
- non-STEMI
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collet JP, Thiele H. The 'Ten Commandments' for the 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2020 Oct 1;41(37):3495-3497. doi: 10.1093/eurheartj/ehaa624. No abstract available.
PubMed 33085966Aktoz M, Altay H, Aslanger E, Atalar E, Aytekin V, Baykan AO, Barcin C, Baris N, Boyaci AA, Cavusoglu Y, Celik A, Cinier G, Degertekin M, Ergonul O, Erturk M, Erol MK, Gorenek B, Gursoy MO, Hunuk B, Kahveci G, Karabay CY, Karaca I, Kayikcioglu M, Keskin M, Kilic T, Kirma C, Kocabas U, Kucukoglu S, Mutlu B, Nalbantgil S, Okuyan E, Okyay K, Kaptan Ozen D, Ozgul S, Ozpelit E, Pirat B, Sert S, Sinan UY, Sener YZ, Tatli E, Tekkesin AI, Tutar E, Ural D, Yildirimturk O. [Consensus Report from Turkish Society of Cardiology: COVID-19 and Cardiovascular Diseases. What cardiologists should know. (25th March 2020)]. Turk Kardiyol Dern Ars. 2020 Mar;48(Suppl 1):1-48. doi: 10.5543/tkda.2020.97198. Turkish.
PubMed 32250347Sabatine MS, Morrow DA, Cannon CP, Murphy SA, Demopoulos LA, DiBattiste PM, McCabe CH, Braunwald E, Gibson CM. Relationship between baseline white blood cell count and degree of coronary artery disease and mortality in patients with acute coronary syndromes: a TACTICS-TIMI 18 (Treat Angina with Aggrastat and determine Cost of Therapy with an Invasive or Conservative Strategy- Thrombolysis in Myocardial Infarction 18 trial)substudy. J Am Coll Cardiol. 2002 Nov 20;40(10):1761-8. doi: 10.1016/s0735-1097(02)02484-1.
PubMed 12446059Azab B, Zaher M, Weiserbs KF, Torbey E, Lacossiere K, Gaddam S, Gobunsuy R, Jadonath S, Baldari D, McCord D, Lafferty J. Usefulness of neutrophil to lymphocyte ratio in predicting short- and long-term mortality after non-ST-elevation myocardial infarction. Am J Cardiol. 2010 Aug 15;106(4):470-6. doi: 10.1016/j.amjcard.2010.03.062.
PubMed 20691303Arbel Y, Finkelstein A, Halkin A, Birati EY, Revivo M, Zuzut M, Shevach A, Berliner S, Herz I, Keren G, Banai S. Neutrophil/lymphocyte ratio is related to the severity of coronary artery disease and clinical outcome in patients undergoing angiography. Atherosclerosis. 2012 Dec;225(2):456-60. doi: 10.1016/j.atherosclerosis.2012.09.009. Epub 2012 Sep 21.
PubMed 23040448Temiz A, Gazi E, Gungor O, Barutcu A, Altun B, Bekler A, Binnetoglu E, Sen H, Gunes F, Gazi S. Platelet/lymphocyte ratio and risk of in-hospital mortality in patients with ST-elevated myocardial infarction. Med Sci Monit. 2014 Apr 22;20:660-5. doi: 10.12659/MSM.890152.
PubMed 24751474Sansanayudh N, Anothaisintawee T, Muntham D, McEvoy M, Attia J, Thakkinstian A. Mean platelet volume and coronary artery disease: a systematic review and meta-analysis. Int J Cardiol. 2014 Aug 20;175(3):433-40. doi: 10.1016/j.ijcard.2014.06.028. Epub 2014 Jun 28.
PubMed 25017904Isik T, Uyarel H, Tanboga IH, Kurt M, Ekinci M, Kaya A, Ayhan E, Ergelen M, Bayram E, Gibson CM. Relation of red cell distribution width with the presence, severity, and complexity of coronary artery disease. Coron Artery Dis. 2012 Jan;23(1):51-6. doi: 10.1097/MCA.0b013e32834e4f5c.
PubMed 22133925Yang YL, Wu CH, Hsu PF, Chen SC, Huang SS, Chan WL, Lin SJ, Chou CY, Chen JW, Pan JP, Charng MJ, Chen YH, Wu TC, Lu TM, Huang PH, Cheng HM, Huang CC, Sung SH, Lin YJ, Leu HB. Systemic immune-inflammation index (SII) predicted clinical outcome in patients with coronary artery disease. Eur J Clin Invest. 2020 May;50(5):e13230. doi: 10.1111/eci.13230. Epub 2020 May 11.
PubMed 32291748
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Predictors in Determining the Need for Invasive Treatment in Non-STEMI During the COVID-19 Pandemic: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04763213
- Acronym / sponsor ID
- non-STEMI / 05.08.2020-2020/15/10
- Conditions
- Myocard Infarctus
- Keywords
- Non-ST elevation myocardial infarction acute coronary syndrome, Neutrophil-lymphocyte ratio, Systemic immune inflammation index, Invasive treatment strategy, Conservative strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Feb 2021 (actual)
- 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.
Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Non-ST elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) is one of the subcomponents of NSTE-ACS, which has an increased mortality rate, and for which early intervention can be vital. Yet, most of these patients require invasive treatment. In fact, some of them are patients who require very early invasive treatment and have a complete occlusion in the culprit artery. Unfortunately, risk scoring systems are not sufficient enough to differentiate these patients. Therefore, the discovery of markers that can be used in the differentiation of NSTEMI-ACS patients with an increased need for invasive treatment and/or complete occlusion of the culprit's vessels, especially during pandemic periods such as the COVID-19 pandemic, has gained importance.
Inflammation is known to play an important role in the etiopathogenesis of coronary artery disease. To the best of our knowledge, there is a lack of literature on the relationship between the need for invasive treatment strategy and/or complete occlusion of the culprit's vessel, and the hematological markers in patients diagnosed with NSTEMI-ACS.
Detailed description
Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Non-ST elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) is one of the subcomponents of NSTE-ACS, which has an increased mortality rate, and for which early intervention can be vital. In the European Society of Cardiology (ESC) guidelines, NSTEMI-ACS is defined as a high-risk condition that requires diagnostic angiography within 2 hours at the latest in those with very high-risk criteria and within 24 hours at the latest in those who do not have high risk. However, the non-invasive approach has come to the fore for the NSTEMI-ACS disease due to the COVID-19 pandemic conditions. In the recently published national consensus report, during the COVID-19 pandemic period, medium-high risk NSTEMI-ACS patients are recommended optimal medical therapy as an alternative treatment method, even if the diagnosis of COVID-19 was excluded, especially in areas where pandemic effects are being experienced intensely. Yet, most of these patients require invasive treatment. In fact, some of them are patients who require very early invasive treatment and have a complete occlusion in the culprit artery. Unfortunately, risk scoring systems are not sufficient enough to differentiate these patients. Therefore, the discovery of markers that can be used in the differentiation of NSTEMI-ACS patients with an increased need for invasive treatment and/or complete occlusion of the culprit's vessels, especially during pandemic periods such as the COVID-19 pandemic, has gained importance.
Inflammation is known to play an important role in the etiopathogenesis of coronary artery disease. In recent years, it has been shown that hematological parameters closely associated with inflammation in people with coronary artery disease may be useful in distinguishing those with increased severity of atherosclerotic involvement and those with high mortality risk. The main markers used in studies are Leukocyte count, neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte Ratio (PLR), systemic immune inflammation index (SII), red blood cell distribution width (RDW), and mean platelet volume (MPV). To the best of our knowledge, there is a lack of literature on the relationship between the need for invasive treatment strategy and/or complete occlusion of the culprit's vessel, and the hematological markers in patients diagnosed with NSTEMI-ACS.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive treatment | – | Diagnostic Test: Coronary AngiographyPatients diagnosed with oclusive or nonoclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting) |
| Medically treatment | – | Diagnostic Test: Coronary AngiographyPatients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 2018 and December 2019, patients admitted to the Cardiology clinic of a tertiary care hospital with a diagnosis of NSTEMI-ACS were evaluated consecutively
Key inclusion criteria (3 listed)
- NonST elevated myocard ınfarctus
- Elder than 18 years
- Patients who were not have the exclusion criterias
Key exclusion criteria (21 listed)
- Under the age of 18,
- Recurrent or ongoing chest pain resistant to drug therapy,
- Hemodynamic instability,
- Life-threatening ventricular arrhythmias or cardiac arrest,
- Development of mechanical complications and the presence of dynamic ST-T wave changes (intermittent ST-segment elevation),
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 |
|---|---|---|
| Coronary AngiographyAlso: Invasive treatmentPatients diagnosed with occlusive or nonocclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting) | Diagnostic test | Invasive treatment, Medically treatment |
| Coronary AngiographyAlso: Medical treatmentPatients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically | Diagnostic test | Invasive treatment, Medically treatment |
Primary outcome
Predictive factors for Non ST elevated MI Blood prarameters Predictive factors for Non ST eleveted MI
Time frame: Pretreatment period
The relationship between inflammation markers such as red cell distribution width (%), mean platelet volume (fL), Systemic immune-inflammation index (platelet count (10^9/L)x neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), neutrophil to lymphocyte ratio (neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), platelet to lymphocyte ratio (neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), and treatment strategy in patients diagnosed with Non-ST myocardial infarction was investigated.
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 21 Feb 2021.
- Results publication: PubMed 33085966Collet JP, Thiele H. The 'Ten Commandments' for the 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2020 Oct 1;41(37):3495-3497. doi: 10.1093/eurheartj/ehaa624. No abstract available.
- Results publication: PubMed 32250347Aktoz M, Altay H, Aslanger E, Atalar E, Aytekin V, Baykan AO, Barcin C, Baris N, Boyaci AA, Cavusoglu Y, Celik A, Cinier G, Degertekin M, Ergonul O, Erturk M, Erol MK, Gorenek B, Gursoy MO, Hunuk B, Kahveci G, Karabay CY, Karaca I, Kayikcioglu M, Keskin M, Kilic T, Kirma C, Kocabas U, Kucukoglu S, Mutlu B, Nalbantgil S, Okuyan E, Okyay K, Kaptan Ozen D, Ozgul S, Ozpelit E, Pirat B, Sert S, Sinan UY, Sener YZ, Tatli E, Tekkesin AI, Tutar E, Ural D, Yildirimturk O. [Consensus Report from Turkish Society of Cardiology: COVID-19 and Cardiovascular Diseases. What cardiologists should know. (25th March 2020)]. Turk Kardiyol Dern Ars. 2020 Mar;48(Suppl 1):1-48. doi: 10.5543/tkda.2020.97198. Turkish.
- Results publication: PubMed 12446059Sabatine MS, Morrow DA, Cannon CP, Murphy SA, Demopoulos LA, DiBattiste PM, McCabe CH, Braunwald E, Gibson CM. Relationship between baseline white blood cell count and degree of coronary artery disease and mortality in patients with acute coronary syndromes: a TACTICS-TIMI 18 (Treat Angina with Aggrastat and determine Cost of Therapy with an Invasive or Conservative Strategy- Thrombolysis in Myocardial Infarction 18 trial)substudy. J Am Coll Cardiol. 2002 Nov 20;40(10):1761-8. doi: 10.1016/s0735-1097(02)02484-1.
- Results publication: PubMed 20691303Azab B, Zaher M, Weiserbs KF, Torbey E, Lacossiere K, Gaddam S, Gobunsuy R, Jadonath S, Baldari D, McCord D, Lafferty J. Usefulness of neutrophil to lymphocyte ratio in predicting short- and long-term mortality after non-ST-elevation myocardial infarction. Am J Cardiol. 2010 Aug 15;106(4):470-6. doi: 10.1016/j.amjcard.2010.03.062.
- Results publication: PubMed 23040448Arbel Y, Finkelstein A, Halkin A, Birati EY, Revivo M, Zuzut M, Shevach A, Berliner S, Herz I, Keren G, Banai S. Neutrophil/lymphocyte ratio is related to the severity of coronary artery disease and clinical outcome in patients undergoing angiography. Atherosclerosis. 2012 Dec;225(2):456-60. doi: 10.1016/j.atherosclerosis.2012.09.009. Epub 2012 Sep 21.
- Results publication: PubMed 24751474Temiz A, Gazi E, Gungor O, Barutcu A, Altun B, Bekler A, Binnetoglu E, Sen H, Gunes F, Gazi S. Platelet/lymphocyte ratio and risk of in-hospital mortality in patients with ST-elevated myocardial infarction. Med Sci Monit. 2014 Apr 22;20:660-5. doi: 10.12659/MSM.890152.
- Results publication: PubMed 25017904Sansanayudh N, Anothaisintawee T, Muntham D, McEvoy M, Attia J, Thakkinstian A. Mean platelet volume and coronary artery disease: a systematic review and meta-analysis. Int J Cardiol. 2014 Aug 20;175(3):433-40. doi: 10.1016/j.ijcard.2014.06.028. Epub 2014 Jun 28.
- Results publication: PubMed 22133925Isik T, Uyarel H, Tanboga IH, Kurt M, Ekinci M, Kaya A, Ayhan E, Ergelen M, Bayram E, Gibson CM. Relation of red cell distribution width with the presence, severity, and complexity of coronary artery disease. Coron Artery Dis. 2012 Jan;23(1):51-6. doi: 10.1097/MCA.0b013e32834e4f5c.
- Results publication: PubMed 32291748Yang YL, Wu CH, Hsu PF, Chen SC, Huang SS, Chan WL, Lin SJ, Chou CY, Chen JW, Pan JP, Charng MJ, Chen YH, Wu TC, Lu TM, Huang PH, Cheng HM, Huang CC, Sung SH, Lin YJ, Leu HB. Systemic immune-inflammation index (SII) predicted clinical outcome in patients with coronary artery disease. Eur J Clin Invest. 2020 May;50(5):e13230. doi: 10.1111/eci.13230. Epub 2020 May 11.
- Individual participant dataSharing planned: No
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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.
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 Myocard Infarctus, run by Kahramanmaras Sutcu Imam 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 3 inclusion and 21 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 21 Feb 2021. 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.
What does the primary outcome measure?
Predictive factors for Non ST elevated MI Blood prarameters Predictive factors for Non ST eleveted MI (time frame: Pretreatment period). 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 NCT04763213, which also lists 9 linked publications.
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 21 Feb 2021.