Clinical trial NCT04549766: Predictive Value of PRECISE DAPT Score in STEMI Patients After Primary PCI
Official title: The Predictive Value of PRECISE DAPT Score in Patients With ST Segment Elevation Myocardial Infarction (STEMI) After Primary Percutaneous Coronary Intervention (PPCI)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed as STEMI accordind to fourth universal definition with age range from 18 to 75 years underwent PPCI at cardiology hospital assiut university hospital eligible for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)

Brief summary: To investigate the predictive value of PRECISE DAPT score in relation to coronary slow flow \& other short term major adverse cardiovascular events (MACE) post PPCI .

Detailed description: Coronary artery disease (CAD) is the leading cause of death around the world and more than 4 million people die every year due to CAD in Europe.\[1\] The incidence of ST elevation myocardial infarction (STEMI) appears to be declining; however, it is still an important issue in cardiovascular medicine.\[2\] Initial risk assessment is important for STEMI to estimate adverse cardiovascular outcomes. Previous studies demonstrated that increased age, advanced Killip class, heart rate, arterial hypotension, increased serum creatinine, white blood cell counts, and hemoglobin levels were predictors of in-hospital and early mortality in patients with STEMI treated with primary percutaneous coronary intervention (PPCI).\[3,4 \]Therefore, risk scores including the aforementioned parameters were developed to estimate mortality in patients with STEMI.

No-reflow is still a challenging major issue in the management of the patients with STEMI undergoing primary PCI. It is defined as inadequate myocardial perfusionthrough a given segment of the coronary circulation without angiographic evidence of mechanical vessel obstructionas \[5\] Angiographic no-reflow defined as less than Thrombolysis In Myocardial Infarction (TIMI) 3 flow \[6\] and angiographic success was defined as TIMI Grade 3 Flow .

PRECISE-DAPT score includes age, creatinine clearance, white blood cell counts, hemoglobin levels, and prior spontaneous bleeding \[7\]. All these factors have a close relationship with coronary artery disease (CAD) and complications \[8-10\]. Therefore, in this study, we aimed to evaluate the association of admission PRECISE-DAPT score with the development of slow flow \& bleeding \& othershort term cardiovascular complications that develop in patients with STEMI treated with primary PCI.

Eligibility criteria: Inclusion Criteria:1.Subjects diagnosed as STEMI accordind to fourth universal definition with age range from 18 to 75 years underwent PPCI at cardiology hospital assiut university hospital.\[11\].

2..Patients elegable for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)\[12\]

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Exclusion Criteria:1-late presentation with STEMI more than 12 hr \& door to ballon more than 120 min including rescue PCI .

2- cardiogenic shock 3-Patients known to have autoimmune disease (e.g vasculitis ) 4- platelate count less than 100000 IU . 5- prothrombin concentration less than 60% 6- Patients taking triple anti thrombotics .

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Primary outcomes:
measure: Follow up complications after PPCI
timeFrame: 3 months
Secondary outcomes:
measure: Predictive value of PRECISE DAPT score
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Aly Mohamed, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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