Left Ventricular ThrombusNCT06152939
Relation of Laboratory Indices to Left Ventricular Thrombus Formation in Patients With Acute Anterior ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention or Thrombolytic Therapy
An observational study of Left Ventricular Thrombus, run by Assiut University.
Trial summary
to find the relationship between the different hematological indices including platelet indices, and blood cell ratios, to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) , or thrombolytic therapy . Read more about this study
- Who is it for?
- Ages 15 to 95 years
- Conditions the study is for
- Left Ventricular Thrombus
- What is being tested?
- Primary percutaneous coronary intervention or thrombolytic therapy
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to Dec 2024
- 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 15 to 95 years
- All sexes
- Child, Adult, Older adult
Study population: Patients present with acute anterior STEMI and undergoing primary percutaneous coronary intervention or thrombolytic therapy in Assiut university heart hospital (AUHH). Patients will be categorized into 2 groups: those with LVT and those without LVT development.
Who may be able to join
- All patients presented to Assiut university cardiac catheterization laboratory with acute anterior STEMI and managed with PPCI or thrombolytic therapy.
Who cannot join
- • Patients not eligible to PPCI
- Patients presented with inferior or lateral STEMI or any type of STEMI other than anterior STEMI.
Trial locations and contacts
No sites are listed yet.
About this study
- to find the relationship between the different hematological indices including platelet indices, and blood cell ratios, to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) , or thrombolytic therapy .
Read the detailed description
ST-segment elevation myocardial infarction (STEMI) has been associated with a high rate of morbidity and mortality (1) Left ventricular thrombus (LVT), one of the most common complications of acute anterior myocardial infarction is linked to the potentially devastating outcome of thromboembolism or stroke [1, 2] , In the era of primary PCI, despite aggressive reperfusion treatment and antithrombotic treatment, the presence of LVT remains high after anterior STEMI), Determining the correlation between clinical and laboratory indicators of thrombosis is the key to the prevention of thromboembolism , The PLR( platelets to lymphocytes ratio ), a new index , provides information about both the inflammatory and thrombosis pathways(3), It is known since long that larger platelets are metabolically and enzymatically more active than small platelets and they have higher thrombotic potentials , that is why MPV , Platelets count , and platelet crit (PCT) are related to platelets activation and they have been suggested as markers of haemostasis , Increase MPV is thought to be associated with thrombus formation in all vascular structures , Recent evidence has shown the meaningful clinical information of the PLR in coronary heart disease and thrombotic diseases (whether diagnostic information or prognostic information). Despite the findings above, data regarding the role of this inflammatory biomarker in LVT are lacking. We conducte a prospective case-control study to explore the correlation between LVT and the PLR and different hematologic indices among anterior STEMI patients with LV dysfunction after primary PCI, or thromolytic therapy, Hematological markers, predictive and even diagnostic value in cardiovascular diseases (CVDs) is a major field of research (4) Leukocytes are considered essential for thrombus formation as well as plaque activation in acute coronary syndrome (ACS). The most reliable indicator of unfavorable outcomes has been proven to be platelet count and may platelet volume, haematocrit, haemoglobin, peak level Troponin and CK-MB (5), Monocytes play a critical role in atherosclerosis by releasing cytokines that are pro-inflammatory and pro-oxidant (6) High values of the monocyte are associated with unfavourable outcomes and severe coronary artery disease (7) ). So, we aimed to find relationship between the different hematological indices and LV thrombus formation in anterior STEMI managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy.
- Conditions
- Left Ventricular Thrombus
- Being tested
- Primary percutaneous coronary intervention or thrombolytic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary percutaneous coronary intervention or thrombolytic therapyOther
Primary percutaneous coronary intervention or thrombolytic therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with acute anterior ST segment elevation myocardial infarction undergoing primary percutaneous coronary intervention . Receives: Other: Primary percutaneous coronary intervention or thrombolytic therapy | |
| 2 | patients with acute anterior ST segment elevation myocardial infarction have thrombolytic therapy . Receives: Other: Primary percutaneous coronary intervention or thrombolytic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relation of different hematological indices to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy .
- To assess the relation of different hematological indices including platelet indices: Mean platelet volume (MPV), Mean platelet component (MPC) , Plateletcrit (PCT), platelet distribution width (PDW), Mean platelet mass (MPM), and blood cell ratios: Neutrophil to lymphocyte ratio (NLR), Platelet to lymphocyte ratio (PLR),White blood cell to Mean platelet volume (WMR) to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy .
Measured: baseline
Secondary outcomes (1)
o Assessment of protein C, S, and activated protein C resistance (APCR) and its relation to LVT development.
- Assessment of protein C, S, and activated protein C resistance (APCR) and its relation to LVT development.
- Relation of the former indices to intracoronary thrombus burden
- Relation of the former indices to major adverse cardiac and cerebrovascular events (MACCEs), both in-hospital and at 3 months
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular ThrombusStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al zahraa Sayed Mahmoud Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152939
- Sponsor's protocol ID
- LV thrombus in anterior STEMI
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Laboratory Indices to Left Ventricular Thrombus Formation in Patients With Acute Anterior ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention or Thrombolytic Therapy
- ClinicalTrials.gov ID
- NCT06152939
- Acronym / sponsor ID
- LV thrombus in anterior STEMI
- Conditions
- Left Ventricular Thrombus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Dec 2023 (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.
- to find the relationship between the different hematological indices including platelet indices, and blood cell ratios, to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) , or thrombolytic therapy .
Detailed description
ST-segment elevation myocardial infarction (STEMI) has been associated with a high rate of morbidity and mortality (1) Left ventricular thrombus (LVT), one of the most common complications of acute anterior myocardial infarction is linked to the potentially devastating outcome of thromboembolism or stroke [1, 2] , In the era of primary PCI, despite aggressive reperfusion treatment and antithrombotic treatment, the presence of LVT remains high after anterior STEMI), Determining the correlation between clinical and laboratory indicators of thrombosis is the key to the prevention of thromboembolism , The PLR( platelets to lymphocytes ratio ), a new index , provides information about both the inflammatory and thrombosis pathways(3), It is known since long that larger platelets are metabolically and enzymatically more active than small platelets and they have higher thrombotic potentials , that is why MPV , Platelets count , and platelet crit (PCT) are related to platelets activation and they have been suggested as markers of haemostasis , Increase MPV is thought to be associated with thrombus formation in all vascular structures , Recent evidence has shown the meaningful clinical information of the PLR in coronary heart disease and thrombotic diseases (whether diagnostic information or prognostic information). Despite the findings above, data regarding the role of this inflammatory biomarker in LVT are lacking. We conducte a prospective case-control study to explore the correlation between LVT and the PLR and different hematologic indices among anterior STEMI patients with LV dysfunction after primary PCI, or thromolytic therapy, Hematological markers, predictive and even diagnostic value in cardiovascular diseases (CVDs) is a major field of research (4) Leukocytes are considered essential for thrombus formation as well as plaque activation in acute coronary syndrome (ACS). The most reliable indicator of unfavorable outcomes has been proven to be platelet count and may platelet volume, haematocrit, haemoglobin, peak level Troponin and CK-MB (5), Monocytes play a critical role in atherosclerosis by releasing cytokines that are pro-inflammatory and pro-oxidant (6) High values of the monocyte are associated with unfavourable outcomes and severe coronary artery disease (7) ). So, we aimed to find relationship between the different hematological indices and LV thrombus formation in anterior STEMI managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Primary percutaneous coronary intervention or thrombolytic therapypatients with acute anterior ST segment elevation myocardial infarction undergoing primary percutaneous coronary intervention . |
| 2 | – | Other: Primary percutaneous coronary intervention or thrombolytic therapypatients with acute anterior ST segment elevation myocardial infarction have thrombolytic therapy . |
Who may qualify
- Ages
- 15 to 95 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients present with acute anterior STEMI and undergoing primary percutaneous coronary intervention or thrombolytic therapy in Assiut university heart hospital (AUHH). Patients will be categorized into 2 groups: those with LVT and those without LVT development.
Key inclusion criteria (1 listed)
- All patients presented to Assiut university cardiac catheterization laboratory with acute anterior STEMI and managed with PPCI or thrombolytic therapy.
Key exclusion criteria (2 listed)
- • Patients not eligible to PPCI
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 |
|---|---|---|
| Primary percutaneous coronary intervention or thrombolytic therapyPrimary percutaneous coronary intervention or thrombolytic therapy | Other | 1, 2 |
Primary outcome
the relation of different hematological indices to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy .
Time frame: baseline
• To assess the relation of different hematological indices including platelet indices: Mean platelet volume (MPV), Mean platelet component (MPC) , Plateletcrit (PCT), platelet distribution width (PDW), Mean platelet mass (MPM), and blood cell ratios: Neutrophil to lymphocyte ratio (NLR), Platelet to lymphocyte ratio (PLR),White blood cell to Mean platelet volume (WMR) to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy .
1 secondary outcome
o Assessment of protein C, S, and activated protein C resistance (APCR) and its relation to LVT development.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Thrombus, 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 2 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 1 Dec 2023. 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 Al zahraa Sayed (01015692124, sayedzahraa570@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relation of different hematological indices to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy . (time frame: baseline). 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 1 Dec 2023.