Clinical trial NCT04290949: Platelet Indices in Patients Undergoing Primary PCI and Its Prognostic Value
Official title: Platelet Indices in Patients Undergoing Primary Percutaneous Coronary Intervention :Its Relation to the Severity of Coronary Artery Disease and Its Prognostic Value
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients presented with acute myocardial infarction who undergoing primary percutaneous intervention

Brief summary: To assess the platelet indices in patients undergoing primary percutaneous coronary intervention and its relation to the severity of coronary artery disease and short term clinical outcomes

Detailed description: Acute coronary syndromes (ACS) is a type of acute coronary artery disease (CAD), It is a highly prevalent group of emergency diseases, associated with high morbidity and mortality (1)

ACS include ST- elevation Myocardial Infarction (STEMI), non ST-Elevation Myocardial Infarction (NSTEMI) and Unstable Angina (UA) (2).

ACS characterized by plaque rupture and acute thrombosis formation in the coronary arteries (3)

platelet morphology and function have vital roles in the pathogenesis of many diseases related to coagulation, thrombosis, inflammation, and endothelial dysfunction (4)

Platelets play a crucial role in thrombotic episodes, its activation is acritical factor in the creation and evolution of atherothrombosis. (5)

Not only platelets are essential for the thrombotic vascular occlusion at the ruptured atherosclerotic plaque but also they contribute to the obstruction and impairment of coronary micro circulation (6).

Risk stratification plays a crucial role in the management of patients with ACS (7).

Patients estimated to be at higher risk may be managed with earlier and more aggressive treatment, whereas those with lower risk may be managed with less intensive treatment (8).

Many biomarkers have been evaluated, and various scores have been created for risk stratification of ACS patients (9)

Mean platelet volume (MPV) has been proposed as a primary marker for platelet activation, as larger sized platelets have been associated with higher pro-thrombotic risk, and its measurement is easy and time effective (10-14)

* So It may elevate in patients with ACS and its role, It could be a useful bio marker of risk of stratification (15)
* Platelet Distribution Width (PDW) measured on admission is a cheap and generally available biomarker which allows for predicting the development of heart failure in patients with ACS after PCI (16)

showed that an increased level of PDW was related to the severity of CAD in patients with ACS (17).

Numerous studies support the association of Mean platelet volume (MPV) with adverse cardiac outcomes as restenosis stent thrombosis in patients with ACS (19-24) al.2011

Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥ 18 years) that presented with acute ST elevation myocardial infarction

Exclusion Criteria:

1. Cardiomyopathy,
2. Previous revascularization procedure
3. Any history of bleeding diathesis

Primary outcomes:
measure: the severity of coronary artery disease and short term clinical outcomes
timeFrame: follow up patients 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Critical Care Unit, Internal Medicine Department
name: Alaa El din Abd El Moniem, Professor
role: STUDY_DIRECTOR
References: