Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Predictors of Thrombus Burden in STEMI Patients and Their Impact on Outcome
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Predictors of Thrombus Burden in STEMI Patients and Their Impact on Outcome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ST-segment elevation myocardial infarction STEMI is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality1 High thrombus burden HTB during ST-segment elevation myocardial infarction STEMI could translate into worse clinical outcomes2 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 andor large reference vessel diameter 35 mm in an occluded IRA3 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 patients6 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 intervention8 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 outcomes9whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients10
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
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 mortality1 High thrombus burden HTB during ST-segment elevation myocardial infarction STEMI could translate into worse clinical outcomes2 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 andor large reference vessel diameter 35 mm in an occluded IRA3 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 patients6 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 intervention8 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 outcomes9whole blood viscosity has also been showing that WBV at both shear rates is a significant predictor of HTB in NSTEMI patients10
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 toolsin detail eg 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
Stroponin
CpkCpk mb
lipid profile
Blood glucose levels at time of admission during hospitalization and at discharge
CRP
HbA1c
Stotal 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 ratio6
B- CRPalbumin 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 level4
C- Tri-glycerides glucose index TyG index is calculated as ln fasting triglycerides mgdL fasting plasma glucose mgdL7
D- Neutrophil-to-lymphocyte ratio Complete blood count is obtained from taken immediately during admission to the emergency departmentNLR values were obtained by dividing the neutrophil count by lymphocyte count5
E- Atherogenic index The atherogenic index is calculated by using the following formula log10 TGHDL-C7 and classified as follows 03 to 01 indicated a low risk 01 to 024 indicated a medium risk and more than 024 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 05 sec-1 were determined using HTC percent and total protein gl levels WBV at HSR 208 sec-1 012 HTC 017 total protein-207 and WBV at LSR 05 sec-1 189 HTC 376 total protein-7842 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 12 or less of the vessel diameter grade 3 G3 there is definite thrombus with greatest linear dimension greater than 12 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
F 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
H In hospital MACE
A total of 0 to 3 points on the HEART score is considered low risk with a risk of 06 to 17 for major adverse cardiac events MACE in the four to six weeks after presentation A score of 4 to 6 is intermediate risk 166 risk of MACE and 7 to 10 points is high risk 501 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
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 toolsin detail eg 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
Stroponin
CpkCpk mb
lipid profile
Blood glucose levels at time of admission during hospitalization and at discharge
CRP
HbA1c
Stotal 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 ratio6
B- CRPalbumin 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 level4
C- Tri-glycerides glucose index TyG index is calculated as ln fasting triglycerides mgdL fasting plasma glucose mgdL7
D- Neutrophil-to-lymphocyte ratio Complete blood count is obtained from taken immediately during admission to the emergency departmentNLR values were obtained by dividing the neutrophil count by lymphocyte count5
E- Atherogenic index The atherogenic index is calculated by using the following formula log10 TGHDL-C7 and classified as follows 03 to 01 indicated a low risk 01 to 024 indicated a medium risk and more than 024 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 05 sec-1 were determined using HTC percent and total protein gl levels WBV at HSR 208 sec-1 012 HTC 017 total protein-207 and WBV at LSR 05 sec-1 189 HTC 376 total protein-7842 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 12 or less of the vessel diameter grade 3 G3 there is definite thrombus with greatest linear dimension greater than 12 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
F 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
H In hospital MACE
A total of 0 to 3 points on the HEART score is considered low risk with a risk of 06 to 17 for major adverse cardiac events MACE in the four to six weeks after presentation A score of 4 to 6 is intermediate risk 166 risk of MACE and 7 to 10 points is high risk 501 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None