NCT06471192

Brief 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). 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

June 18, 2024

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (1)

  • Impact of these factors on patients outcomes at 6 months.

    18 months

Interventions

PPCIPROCEDURE

PPCI for patients of STEMI to assess thrombus burden

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Soheir Kasem, Professor

    Soher.Kasem@yahoo.com

    STUDY DIRECTOR

Central Study Contacts

Alaaeldin Abdelrahman, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

July 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

June 24, 2024

Record last verified: 2024-06