AzTrials
AzTrials

STEMINCT06471192

Predictors of Thrombus Burden in STEMI Patients and Their Impact on Outcome

An observational study of STEMI, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Alaaeldin Abdelrahman, MSc contact

01144780935

aladdinmahmoid@aun.edu.eg

Salma Osman, MD contact

01098212915

salmamokhtar@aun.edu.eg

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.

  1. 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.

  1. 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.

  1. 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)
  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.

  1. First posted24 Jun 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in