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

STEMI Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123793
• Other study ID #: Predictors of outcomes in MI
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Abdelrahman R. Kamel, MBBS
• Phone: +20 01002251849
• Email: Ab.ragabk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• ST Elevation Myocardial Infarction
• STEMI

Locations

Country	Name	City	State
Egypt	Abdelrahman Ragab	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Ayca B, Akin F, Celik O, Cetin S, Sahin I, Gulsen K, Kalyoncuoglu M, Katkat F, Okuyan E, Dinckal MH. Does SYNTAX score predict in-hospital outcomes in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention? Kardiol Pol. 2014;72(9):806-13. doi: 10.5603/KP.a2014.0064. Epub 2014 Mar 27. — View Citation

Dai C, Liu M, Zhou Y, Lu D, Li C, Chang S, Chen Z, Qian J, Ge J. A score system to predict no-reflow in primary percutaneous coronary intervention: The PIANO Score. Eur J Clin Invest. 2022 Feb;52(2):e13686. doi: 10.1111/eci.13686. Epub 2021 Oct 11. — View Citation

Dai C, Yang Z, Liu M, Zhou Y, Lu D, Chang S, Li C, Lu H, Chen Z, Qian J, Ge J. Prognostic value and clinical usefulness of PIANO score in patients undergoing primary percutaneous coronary intervention. Int J Cardiol. 2023 Nov 1;390:131258. doi: 10.1016/j.ijcard.2023.131258. Epub 2023 Aug 17. — View Citation

Hizoh I, Domokos D, Banhegyi G, Becker D, Merkely B, Ruzsa Z. Mortality prediction algorithms for patients undergoing primary percutaneous coronary intervention. J Thorac Dis. 2020 Apr;12(4):1706-1720. doi: 10.21037/jtd.2019.12.83. Erratum In: J Thorac Dis. 2020 Jul;12(7):3913-3917. — View Citation

Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054. — View Citation

Pantea-Rosan LR, Pantea VA, Bungau S, Tit DM, Behl T, Vesa CM, Bustea C, Moleriu RD, Rus M, Popescu MI, Turi V, Diaconu CC. No-Reflow after PPCI-A Predictor of Short-Term Outcomes in STEMI Patients. J Clin Med. 2020 Sep 12;9(9):2956. doi: 10.3390/jcm9092956. — View Citation

Peker T, Boyraz B. Short-Term Prognostic Value of the Culprit-SYNTAX Score in Patients with Acute Myocardial Infarction. J Cardiovasc Dev Dis. 2023 Jun 24;10(7):270. doi: 10.3390/jcdd10070270. — View Citation

Tanik VO, Cinar T, Arugaslan E, Karabag Y, Hayiroglu MI, Cagdas M, Rencuzogullari I, Uluganyan M. The Predictive Value of PRECISE-DAPT Score for In-Hospital Mortality in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Angiology. 2019 May;70(5):440-447. doi: 10.1177/0003319718807057. Epub 2018 Oct 15. — View Citation

Taniwaki M, Stefanini GG, Raber L, Brugaletta S, Cequier A, Heg D, Iniguez A, Kelbaek H, Serra A, Ostoijic M, Hernandez-Antolin R, Baumbach A, Blochlinger S, Juni P, Mainar V, Sabate M, Windecker S. Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials. EuroIntervention. 2015 Aug;11(4):391-8. doi: 10.4244/EIJY14M07_12. — View Citation

Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no-reflow PIANO score as predictor of cumulative MACE	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.	3 months
Primary	culprit-SYNTAX score as predictor of cumulative MACE	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.	3 months