STEMINCT06471192
Predictors of Thrombus Burden in STEMI Patients and Their Impact on Outcome
An observational study of STEMI, run by Assiut University.
Trial summary
ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality.(1). High thrombus burden (HTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes.(2). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- STEMI
- What is being tested?
- PPCI
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2025
- 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: All patients admitted with STEMI undergoing PPCI will be recruited in the study and the period of data collection will be continued for 12 months. Total number that will be recruited will be at least 200 cases.
Who may be able to join
- All patients admitted with STEMI undergoing PPCI will be recruited in the study and the period of data collection will be continued for 12 months. Total number that will be recruited will be at least 200 cases.
Who cannot join
- known chronic inflammatory disease, neoplasms or severe hepatic disease; end-stage renal disorder (estimated glomerular filtration rate < 30 ml/min/1.73 m2); undergoing renal replacement therapy; no intracoronary lesions shown via angiography; history of cardiac valve surgery; using oral anticoagulants;
Trial locations and contacts
No sites are listed yet.
About this study
ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality.(1). High thrombus burden (HTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes.(2). HTB has been defined as the occurrence of thrombo- sis during myocardial infarction, as determined by a thrombus score ≥ 3 in the infarct-related artery (IRA) or as a "cut-off" occlusion pattern and/or large reference vessel diameter (≥ 3.5 mm) in an occluded IRA.(3) Many variables were used to predict the presence of high thrombus burden in STEMI patients undergoing primary PCI. higher C-reactive protein, and low serum albumin, higher C - reactive protein to albumin ratio (4) which can be used as a surrogate marker of pro-inflammation and is closely related to pro-thrombotic state. Furthermore higher neutrophil-lymphocyte ratio is closely associated with HTB and short-term mortality in STEMI patients (5). MAPH score, which is a new score that combines blood viscosity biomarkers such as mean platelet volume (MPV), total protein and hematocrit, can be used to predict thrombus burden in ST-segment elevation myocardial infarction (STEMI) patients.(6). In addition, TyG index, a valid surrogate marker of insulin resistance, is an independent predictor of LTB in STEMI patients who underwent primary PCI and can be used as an indicator of increased intracoronary thrombus burden. (7). Furthermore, Initial troponin level may be associated with larger thrombus burden within a coronary artery. This finding may influence coronary flow and needs to be taken into consideration during primary coronary intervention.(8). The atherogenic index, a logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol, can be used as a reliable marker for increased coronary thrombus burden, which is associated with adverse cardiovascular outcomes(9).whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients(10).
In our research, we aim to study the effect of these different parameters on thrombus burden and their impact on patients outcome at 6 months
Read the detailed description
ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality.(1). High thrombus burden (HTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes.(2). HTB has been defined as the occurrence of thrombo- sis during myocardial infarction, as determined by a thrombus score ≥ 3 in the infarct-related artery (IRA) or as a "cut-off" occlusion pattern and/or large reference vessel diameter (≥ 3.5 mm) in an occluded IRA.(3) Many variables were used to predict the presence of high thrombus burden in STEMI patients undergoing primary PCI. higher C-reactive protein, and low serum albumin, higher C - reactive protein to albumin ratio (4) which can be used as a surrogate marker of pro-inflammation and is closely related to pro-thrombotic state. Furthermore higher neutrophil-lymphocyte ratio is closely associated with HTB and short-term mortality in STEMI patients (5). MAPH score, which is a new score that combines blood viscosity biomarkers such as mean platelet volume (MPV), total protein and hematocrit, can be used to predict thrombus burden in ST-segment elevation myocardial infarction (STEMI) patients.(6). In addition, TyG index, a valid surrogate marker of insulin resistance, is an independent predictor of LTB in STEMI patients who underwent primary PCI and can be used as an indicator of increased intracoronary thrombus burden. (7). Furthermore, Initial troponin level may be associated with larger thrombus burden within a coronary artery. This finding may influence coronary flow and needs to be taken into consideration during primary coronary intervention.(8). The atherogenic index, a logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol, can be used as a reliable marker for increased coronary thrombus burden, which is associated with adverse cardiovascular outcomes(9).whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients(10).
In our research, we aim to study the effect of these different parameters on thrombus burden and their impact on patients outcome at 6 months
Study tools(in detail, e.g., lab methods, instruments, steps, chemicals, …):
A-History taking:
Patients' data will be collected, included age, gender and comorbidities.
B- physical examination including:
- Waist -to-hip ratio
- Body mass index (BMI)
- Waist circumference
- Systolic, diastolic and mean blood pressure C- Laboratory investigations
- Complete blood picture (CBC)
- S. Urea, S. Creatinine (Cr), uric acid (UA), S. Sodium, S. Potassium
- S.troponin
- Cpk,Cpk mb
- lipid profile
- Blood glucose levels at time of admission ,during hospitalization and at discharge
- CRP
- HbA1c
- S.total protein, S. ALB D- 12 lead ECG E-Score and ratio calculations A- MAPH score The predictive cut-off values of MPV, total protein, age and hematocrit for high thrombus grade were determined using the Youden index. The values higher from the cut-off were considered as a score of 1 and MAPH score was calculated as the sum score of 0 or 1 by the cut-off in each ratio.(6).
B- CRP/albumin ratio SA and CRP levels are obtained from the results of blood samples taken immediately during admission to the emergency department. CAR values were obtained by dividing the CRP level by the SA level.(4).
C- Tri-glycerides glucose index TyG index is calculated as ln [fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL).(7).
D- Neutrophil-to-lymphocyte ratio Complete blood count is obtained from taken immediately during admission to the emergency department.NLR values were obtained by dividing the neutrophil count by lymphocyte count.(5).
E- Atherogenic index The atherogenic index is calculated by using the following formula: log10 (TG/HDL-C)7 and classified as follows: 0.3 to 0.1 indicated a low risk, 0.1 to 0.24 indicated a medium risk, and more than 0.24 indicated a high risk of CVD. (9).
F- Whole blood viscosity WBV at a high shear rate (HSR) (208 sec-1) and a low shear rate (LSR) (0.5 sec-1) were determined using HTC (percent) and total protein (g/l) levels; WBV at HSR (208 sec-1) = (0.12 × HTC) + (0.17 × [total protein-2.07]) and WBV at LSR (0.5 sec-1) = (1.89 × HTC) + (3.76 × [total protein-78.42]) (10)
E-Angiographic analysis for determination of thrombus burden:
The angiographic data will be revised by two experienced interventional cardiologists. Intracoronary thrombus at baseline are angiographically identified and scored according to Thrombolysis in Myocardial Infarction (TIMI) thrombus grade (11). grade 0 (G0) no angiographic characteristics of thrombus are present; grade 1 (G1) possible thrombus is present, with angiographic characteristics as reduced contrast density, haziness, irregular lesion contour, or a smooth convex meniscus, suggestive but not diagnostic of thrombus; grade 2 (G2) there is definite thrombus with greatest dimensions 1/2 or less of the vessel diameter; grade 3 (G3) there is definite thrombus with greatest linear dimension greater than 1/2 but less than 2 vessel diameters; grade 4 (G4) there is definite thrombus with the largest dimension at least 2 vessel diameters; grade 5 (G5) there is total occlusion.
- Type of stent G. Echocardiography: for assessment of left side function systolic and diastolic function, right side systolic function \& valvular affection.
All echocardiographic measurements will be performed according to the recommendations of the American Society of Echocardiography using a high -resolution Phillips machine.
- In hospital MACE
A total of 0 to 3 points on the HEART score is considered low risk, with a risk of 0.6% to 1.7% for major adverse cardiac events (MACE) in the four to six weeks after presentation. A score of 4 to 6 is intermediate risk (16.6% risk of MACE), and 7 to 10 points is high risk (50.1% risk of MACE). (12)
Clinical follow-up:
Information about the survival status of all patients through hospital records and contact with patients and their relatives.
Information on hospitalization and cardiovascular events will be obtained through health questionnaires. If necessary, referring cardiologists and general practitioners were contacted for additional data. In case of re-hospitalization medical records or discharge letters from other hospitals will be collected. Clinical follow-up was performed at 6 months.
- Conditions
- STEMI
- Being tested
- PPCI
- 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.
PPCIProcedure or surgery
PPCI for patients of STEMI to assess thrombus burden
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect different factors on thrombus burden in patients with STEMI.
To evaluate the effect different factors on thrombus burden in patients with STEMI.
Measured: 1 year
Secondary outcomes (1)
Impact of these factors on patients outcomes at 6 months.
Impact of these factors on patients outcomes at 6 months.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaaeldin Abdelrahman, Assiut University
- Investigators
- Soheir Kasem, Professor, Study director, Soher.Kasem@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471192
- Sponsor's protocol ID
- predictors of thrombus burden
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Thrombus Burden in STEMI Patients and Their Impact on Outcome
- ClinicalTrials.gov ID
- NCT06471192
- Acronym / sponsor ID
- predictors of thrombus burden
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jun 2024 (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.
ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality.(1). High thrombus burden (HTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes.(2). HTB has been defined as the occurrence of thrombo- sis during myocardial infarction, as determined by a thrombus score ≥ 3 in the infarct-related artery (IRA) or as a "cut-off" occlusion pattern and/or large reference vessel diameter (≥ 3.5 mm) in an occluded IRA.(3) Many variables were used to predict the presence of high thrombus burden in STEMI patients undergoing primary PCI. higher C-reactive protein, and low serum albumin, higher C - reactive protein to albumin ratio (4) which can be used as a surrogate marker of pro-inflammation and is closely related to pro-thrombotic state. Furthermore higher neutrophil-lymphocyte ratio is closely associated with HTB and short-term mortality in STEMI patients (5). MAPH score, which is a new score that combines blood viscosity biomarkers such as mean platelet volume (MPV), total protein and hematocrit, can be used to predict thrombus burden in ST-segment elevation myocardial infarction (STEMI) patients.(6). In addition, TyG index, a valid surrogate marker of insulin resistance, is an independent predictor of LTB in STEMI patients who underwent primary PCI and can be used as an indicator of increased intracoronary thrombus burden. (7). Furthermore, Initial troponin level may be associated with larger thrombus burden within a coronary artery. This finding may influence coronary flow and needs to be taken into consideration during primary coronary intervention.(8). The atherogenic index, a logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol, can be used as a reliable marker for increased coronary thrombus burden, which is associated with adverse cardiovascular outcomes(9).whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients(10).
In our research, we aim to study the effect of these different parameters on thrombus burden and their impact on patients outcome at 6 months
Detailed description
ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality.(1). High thrombus burden (HTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes.(2). HTB has been defined as the occurrence of thrombo- sis during myocardial infarction, as determined by a thrombus score ≥ 3 in the infarct-related artery (IRA) or as a "cut-off" occlusion pattern and/or large reference vessel diameter (≥ 3.5 mm) in an occluded IRA.(3) Many variables were used to predict the presence of high thrombus burden in STEMI patients undergoing primary PCI. higher C-reactive protein, and low serum albumin, higher C - reactive protein to albumin ratio (4) which can be used as a surrogate marker of pro-inflammation and is closely related to pro-thrombotic state. Furthermore higher neutrophil-lymphocyte ratio is closely associated with HTB and short-term mortality in STEMI patients (5). MAPH score, which is a new score that combines blood viscosity biomarkers such as mean platelet volume (MPV), total protein and hematocrit, can be used to predict thrombus burden in ST-segment elevation myocardial infarction (STEMI) patients.(6). In addition, TyG index, a valid surrogate marker of insulin resistance, is an independent predictor of LTB in STEMI patients who underwent primary PCI and can be used as an indicator of increased intracoronary thrombus burden. (7). Furthermore, Initial troponin level may be associated with larger thrombus burden within a coronary artery. This finding may influence coronary flow and needs to be taken into consideration during primary coronary intervention.(8). The atherogenic index, a logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol, can be used as a reliable marker for increased coronary thrombus burden, which is associated with adverse cardiovascular outcomes(9).whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients(10).
In our research, we aim to study the effect of these different parameters on thrombus burden and their impact on patients outcome at 6 months
Study tools(in detail, e.g., lab methods, instruments, steps, chemicals, …):
A-History taking:
Patients' data will be collected, included age, gender and comorbidities.
B- physical examination including:
- Waist -to-hip ratio
- Body mass index (BMI)
- Waist circumference
- Systolic, diastolic and mean blood pressure C- Laboratory investigations
- Complete blood picture (CBC)
- S. Urea, S. Creatinine (Cr), uric acid (UA), S. Sodium, S. Potassium
- S.troponin
- Cpk,Cpk mb
- lipid profile
- Blood glucose levels at time of admission ,during hospitalization and at discharge
- CRP
- HbA1c
- S.total protein, S. ALB D- 12 lead ECG E-Score and ratio calculations A- MAPH score The predictive cut-off values of MPV, total protein, age and hematocrit for high thrombus grade were determined using the Youden index. The values higher from the cut-off were considered as a score of 1 and MAPH score was calculated as the sum score of 0 or 1 by the cut-off in each ratio.(6).
B- CRP/albumin ratio SA and CRP levels are obtained from the results of blood samples taken immediately during admission to the emergency department. CAR values were obtained by dividing the CRP level by the SA level.(4).
C- Tri-glycerides glucose index TyG index is calculated as ln [fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL).(7).
D- Neutrophil-to-lymphocyte ratio Complete blood count is obtained from taken immediately during admission to the emergency department.NLR values were obtained by dividing the neutrophil count by lymphocyte count.(5).
E- Atherogenic index The atherogenic index is calculated by using the following formula: log10 (TG/HDL-C)7 and classified as follows: 0.3 to 0.1 indicated a low risk, 0.1 to 0.24 indicated a medium risk, and more than 0.24 indicated a high risk of CVD. (9).
F- Whole blood viscosity WBV at a high shear rate (HSR) (208 sec-1) and a low shear rate (LSR) (0.5 sec-1) were determined using HTC (percent) and total protein (g/l) levels; WBV at HSR (208 sec-1) = (0.12 × HTC) + (0.17 × [total protein-2.07]) and WBV at LSR (0.5 sec-1) = (1.89 × HTC) + (3.76 × [total protein-78.42]) (10)
E-Angiographic analysis for determination of thrombus burden:
The angiographic data will be revised by two experienced interventional cardiologists. Intracoronary thrombus at baseline are angiographically identified and scored according to Thrombolysis in Myocardial Infarction (TIMI) thrombus grade (11). grade 0 (G0) no angiographic characteristics of thrombus are present; grade 1 (G1) possible thrombus is present, with angiographic characteristics as reduced contrast density, haziness, irregular lesion contour, or a smooth convex meniscus, suggestive but not diagnostic of thrombus; grade 2 (G2) there is definite thrombus with greatest dimensions 1/2 or less of the vessel diameter; grade 3 (G3) there is definite thrombus with greatest linear dimension greater than 1/2 but less than 2 vessel diameters; grade 4 (G4) there is definite thrombus with the largest dimension at least 2 vessel diameters; grade 5 (G5) there is total occlusion.
- Type of stent G. Echocardiography: for assessment of left side function systolic and diastolic function, right side systolic function \& valvular affection.
All echocardiographic measurements will be performed according to the recommendations of the American Society of Echocardiography using a high -resolution Phillips machine.
- In hospital MACE
A total of 0 to 3 points on the HEART score is considered low risk, with a risk of 0.6% to 1.7% for major adverse cardiac events (MACE) in the four to six weeks after presentation. A score of 4 to 6 is intermediate risk (16.6% risk of MACE), and 7 to 10 points is high risk (50.1% risk of MACE). (12)
Clinical follow-up:
Information about the survival status of all patients through hospital records and contact with patients and their relatives.
Information on hospitalization and cardiovascular events will be obtained through health questionnaires. If necessary, referring cardiologists and general practitioners were contacted for additional data. In case of re-hospitalization medical records or discharge letters from other hospitals will be collected. Clinical follow-up was performed at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted with STEMI undergoing PPCI will be recruited in the study and the period of data collection will be continued for 12 months. Total number that will be recruited will be at least 200 cases.
Key inclusion criteria (1 listed)
- All patients admitted with STEMI undergoing PPCI will be recruited in the study and the period of data collection will be continued for 12 months. Total number that will be recruited will be at least 200 cases.
Key exclusion criteria (1 listed)
- known chronic inflammatory disease, neoplasms or severe hepatic disease; end-stage renal disorder (estimated glomerular filtration rate < 30 ml/min/1.73 m2); undergoing renal replacement therapy; no intracoronary lesions shown via angiography; history of cardiac valve surgery; using oral anticoagulants;
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 |
|---|---|---|
| PPCIPPCI for patients of STEMI to assess thrombus burden | Procedure or surgery | – |
Primary outcome
To evaluate the effect different factors on thrombus burden in patients with STEMI.
Time frame: 1 year
To evaluate the effect different factors on thrombus burden in patients with STEMI.
1 secondary outcome
Impact of these factors on patients outcomes at 6 months.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Soheir Kasem, Professor study director
Soher.Kasem@yahoo.com
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaaeldin Abdelrahman, MSc (01144780935, aladdinmahmoid@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect different factors on thrombus burden in patients with STEMI. (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 24 Jun 2024.