Predictors of In-hospital and Short-term Clinical Outcomes in STEMI Patients Undergoing Primary PCI

Recruiting

• Conditions: STEMI

• Registration Number: NCT06123793
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Study Start: 2023-11-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-10
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
no-reflow PIANO score as predictor of cumulative MACE	3 months	Assess the role of The PIANO ( PredIction of Angiographic NO-reflow ) score as a predictor of cumulative (in-hospital and short-term) MACE over 3 months period in STEMI patients undergoing primary PCI; The PIANO score ranges from 0 - 14 and it predicts NO Reflow (a complication of PCI), patients with higher scores have a higher risk of developing NO Reflow as a complication; The PIANO score depends on the following: * Age ≥70 years,( 2 points ); * absence of pre-infarction angina ( 3 points ); * total ischemic time ≥4 h ( 1 point ); * left anterior descending as the culprit artery ( 1 point ); * pre-PCI TIMI flow grade ≤1 ( 2 points ) pre-PCI TIMI thrombus score ≥4 ( 5 points ); we will look if patients undergoing primary PCI with high PIANO scores will have a higher risk of poor outcomes.
culprit-SYNTAX score as predictor of cumulative MACE	3 months	SYNTAX score ( Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) is a well-known score that assesses the severity and complexity of coronary artery disease and helps in choosing a treatment plan.; - it ranges from 0 with no predefined maximum score, and it is calculated according to several angiographic parameters using this online calculator tool:https://syntaxscore.org/calculator/start.htm).; the SYNTAX score can be calculated only for the culprit vessel ( culprit-SYNTAX) score; we will look if patients undergoing primary PCI with high culprit-SYNTAX scores will have a higher risk of poor outcomes.

Trial Locations

Locations (1)

Abdelrahman Ragab; 🇪🇬 Assiut, Egypt