Clinical trial NCT06123793: Predictors of In-hospital and Short-term Clinical Outcomes in STEMI Patients Undergoing Primary PCI
Official title: Assessment of Culprit-SYNTAX Score and No-reflow PIANO Score as Predictors of In-hospital and Short-term Clinical Outcomes in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: STEMI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients presenting to Assiut University Heart Hospital with STEMI and undergoing primary PCI, each patient will be followed up 3 months post-PCI.

Brief summary: The study aims to assess the culprit-SYNTAX score and no-reflow PIANO scores as possible predictors of in-hospital and short-term outcomes among patients with STEMI undergoing primary PCI

Detailed description: ST-elevation myocardial infarction (STEMI) is the leading cause of death in cardiovascular patients. Percutaneous coronary intervention (PCI) is recommended as the preferred treatment for patients with STEMI. However, patients with (STEMI) undergoing primary (PCI) remain at high risk of adverse events, including death, reinfarction, stent thrombosis, and repeat revascularization. This underlines the need to identify predictors of impaired clinical outcomes in order to recognize higher-risk patients in the contemporary practice of primary PCI. STEMI patients show variable mortality risks, in order to assess individual risk, a number of mathematical models (scoring algorithms) have been developed as TIMI, GRACE 2.0, and ALPHA scores Similarly, angiographic scores were developed to assess the outcomes in STEMI patients, SYNTAX Score, has shown predictive value of in-hospital mortality among STEMI patients. Recently, the culprit-SYNTAX score appears to be as successful as the SYNTAX score in predicting stent thrombosis in patients with ACS and more successful in predicting 30-day deaths and major complications.

The no-flow phenomenon (NRP), one of the most common complications of primary PCI, significantly reduces the benefit of this procedure. The occurrence of NRP following PPCI leads to an unfavorable short-term prognosis by increasing the risk of complications and in some cases, of death. A new score system (the PIANO score) based on six clinical variables was constructed and validated, was variables to predict angiographic no-reflow in STEMI patients undergoing primary PCI, and very recently showed potential prognostic value in patients with AMI undergoing primary PCI.

Eligibility criteria: Inclusion Criteria:

Patients presented with 1st episode of STEMI and undergoing primary PCI. For 1 year duration.

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Exclusion Criteria:

1. Patient with STEMI in which thrombolytic therapy was used.
2. Patient with a history of previous CABG surgery.
3. Patient with a history of previous PCI.
4. Patient with a history of previous STEMI.
5. Patients with myocardial infarction with non-obstructive coronary arteries (MINOCA)
6. Patient with spontaneous coronary artery dissection (SCAD).

Primary outcomes:
measure: no-reflow PIANO score as predictor of cumulative MACE
timeFrame: 3 months
measure: culprit-SYNTAX score as predictor of cumulative MACE
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Abdelrahman Ragab
Study officials:
affiliation: Professor at cardiovascular medicine department , assiut university
name: Salwa R. Demitry, PhD
role: STUDY_DIRECTOR
References:
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