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

NCT06123793 | Unknown

• 1 other identifier: Predictors of outcomes in MI
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

STEMI

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Abdelrahman Ragab

Asyut, Egypt

RECRUITING

Related Publications (10)

• 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.

  PMID: 30322265 BACKGROUND

• 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.

  PMID: 10547403 BACKGROUND

• 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.

  PMID: 25042419 BACKGROUND

• 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.

  PMID: 32395313 BACKGROUND

• 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.

  PMID: 24671913 BACKGROUND

• 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.

  PMID: 37504526 BACKGROUND

• 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.

  PMID: 20488311 BACKGROUND

• 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.

  PMID: 32932736 BACKGROUND

• 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.

  PMID: 34596236 BACKGROUND

• 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.

  PMID: 37574024 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Salwa R. Demitry, PhD

  Professor at cardiovascular medicine department , assiut university

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman R. Kamel, MBBS

CONTACT

+20 01002251849; Ab.ragabk@gmail.com

Heba M. El-Naggar, PhD

CONTACT

+20 01001963100; heba_m_elnaggar@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: November 9, 2023
• Study Start: November 10, 2023
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

EG (1)