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RecruitingNCT06123793Updated Dec 11, 2023

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

An observational study in STEMI, sponsored by Assiut University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study 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

Read the 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.

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Conditions studied

03

In context

ST Elevation Myocardial Infarction

667 studies on the registry are indexed under ST Elevation Myocardial Infarction; 180 are open to participants now.

This study's planned enrollment of 500 is above the median of 329 across 222 observational studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

-

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Abdelrahman Ragab
    Assiut, Egypt
    • Abdelrahman Ragab · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 30322265 ↗
  • 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. PubMed 10547403 ↗
  • 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. PubMed 25042419 ↗
  • 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. doi: 10.21037/jtd-2020-56. PubMed 32395313 ↗
  • 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. PubMed 24671913 ↗
  • 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. PubMed 37504526 ↗
  • 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. PubMed 20488311 ↗
  • 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. PubMed 32932736 ↗
  • 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. PubMed 34596236 ↗
  • 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. PubMed 37574024 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06123793
Lead sponsor
Assiut University
Responsible party
Abdelrahman Ragab Kamel (Doctor, Assiut University) — Principal investigator
First posted
Nov 9, 2023
Start date
Nov 10, 2023
Primary completion
Oct 2024 (estimated)
Completion
Feb 2025 (estimated)
Last update
Dec 11, 2023

Study contacts

Abdelrahman R. Kamel, MBBS
Contact
Ab.ragabk@gmail.com
+20 01002251849
Heba M. El-Naggar, PhD
Contact
heba_m_elnaggar@yahoo.com
+20 01001963100
Salwa R. Demitry, PhD
study director · Professor at cardiovascular medicine department , assiut university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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