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

December 5, 2023 updated by: Abdelrahman Ragab Kamel, Assiut University

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

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

Study Overview

Status

Recruiting

Conditions

STEMI

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Abdelrahman R. Kamel, MBBS
Phone Number: +20 01002251849
Email: Ab.ragabk@gmail.com

Study Contact Backup

Name: Heba M. El-Naggar, PhD
Phone Number: +20 01001963100
Email: heba_m_elnaggar@yahoo.com

Study Locations

Egypt
- - Assiut, Egypt
    - Recruiting
    - Abdelrahman Ragab
    - Contact:
      
      Abdelrahman Ragab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
no-reflow PIANO score as predictor of cumulative MACE Time Frame: 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.	3 months
culprit-SYNTAX score as predictor of cumulative MACE Time Frame: 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.	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Director: Salwa R. Demitry, PhD, Professor at cardiovascular medicine department , assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Predictors of outcomes in MI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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