Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of ACS Patients With Multi-Vessel Disease

February 15, 2022 updated by: Amr Abdelbadee Abdelhameed Othman, Assiut University

Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of Acute Coronary Syndrome Patients With Multi-Vessel Disease

The investigators want to assess the use of the residual SYNTAX score and the SYNTAX Revascularization Index as predictors for in-hospital outcomes and mid-term (6 months to 1 year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS. Both values will be calculated in a number of patients over one year, and the relationship between both values and patient outcomes will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Significant non-culprit coronary stenosis is noted in 40-70% of patients with ST-elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Presence of multivessel disease (MVD) has been associated with poorer clinical outcomes. MVD in STEMI may confer an increased risk of recurrent ischemia and mortality. However, the impact of MVD on prognosis in STEMI may vary depending on the characteristics of coronary artery disease (CAD) present.

Current guidelines recommend that only the infarct-related artery should be treated. However, RCTs have suggested that a strategy of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure, may be beneficial and safe in selected patients with STEMI. On the basis of these findings, the prior Class III (Harm) recommendation with regard to multivessel primary PCI in hemodynamically stable patients with STEMI has been upgraded and modified to a Class IIb recommendation to include consideration of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure.

Early invasive treatment in high-risk patients with non-ST-elevation acute coronary syndrome (NSTEACS) has been shown to improve their prognosis in terms of cardiovascular death and reinfarction. The prevalence of multivessel disease in these patients stands at about 50% and experts agree that performing complete revascularization is beneficial in such patients.

Accordingly, the SYNergy between PCI with TAXus and cardiac surgery (SYNTAX) score has been developed in 2005 in Erasmus Medical Center in the Netherlands to evaluate the severity of coronary artery disease in the settings of left main or MVD.

The investigators have observed a growing interest in residual disease burden after PCI. The residual SYNTAX score (rSS), described by Genereux and colleagues is a strong prognostic factor of coronary events and all-cause death in patients who have undergone PCI. This score has subsequently been validated by other groups and been shown to have good prognostic accuracy for adverse ischemic outcomes after PCI.

The SYNTAX Revascularisation Index (SRI), which takes into account the severity and extent of baseline CAD (as assessed by the baseline SYNTAX score [bSS]) and the residual CAD after PCI (as assessed by the rSS) has been used in determining the proportion of CAD that has been treated, and has been shown to have prognostic utility in PCI for MVD.

Here, the investigators want to assess the use of the residual SYNTAX score and the SYNTAX Revascularization Index as predictors for in-hospital outcomes and mid-term (up to two year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS.

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university heart hospital

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive patients admitted to the Assiut University Hospitals Department of Cardiology will be collected over one year starting 1st of July 2017 till 30th of June 2018.

Considering the primary end-point of the study (MACE rate 28%) (Khan et al, 2016), the estimated sample size of the population, based on power of 85%, and alpha= 5%, is calculated to be = 108 patients.

Description

Inclusion Criteria:

  • All ACS (STEMI and NSTEACS) patients undergoing PCI in the setting of MVD.

Exclusion Criteria:

  • Patients receiving fibrinolytic therapy.
  • Patients with cardiogenic shock
  • Post-CABG patients
  • Patients with severe renal impairment

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Group
Acute Coronary Syndrome Patients With Multi-Vessel Disease. The Residual SYNTAX score (rSS) and the SYNTAX Revascularization Index (SRI) will be calculated in this group and its relationship with patient outcomes either in hospital or in 6 months to 1 year follow-up will be evaluated.
Diagnostic test: Residual SYNTAX Score

The baseline SYNTAX score and the residual SYNTAX score (rSS) are calculated by summing up the individual scores for each lesion with a diameter stenosis ≥50% in vessels with a diameter ≥ 1.5 mm in the angiography obtained before and after the procedure. The SYNTAX algorithm of scoring is fully described elsewhere.

The modified Age, Creatinine, and Ejection Fraction (ACEF) score is calculated based on the age, creatinine clearance (CrCl) and left ventricular ejection fraction (LVEF), using the formula age/LVEF +1 point for every 10 ml/min/1.73 m2 reduction of CrCl below 60 ml/min/1.73 m2 (1 point for CrCl between 59 and 50, 2 points for CrCl between 49 and 40 and 3 points for CrCl between 39 and 30 ml/min/1.73 m2). The CrCl is calculated via the Cockroft-Gault equation using age, gender weight and serum creatinine before PCI. The baseline SYNTAX score was then multiplied by the modified ACEF score to obtain the baseline clinical SYNTAX score.

Diagnostic test: SYNTAX Revascularization Index
The SYNTAX Revascularization Index (SRI), representing the proportion of CAD burden treated by PCI, was calculated using the following formula: SRI= (1-[rSS/bSS]) ×100.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital major adverse cardiac events (MACE)
Time Frame: 2 Years
A composite of cardiac death (including periprocedural), non-fatal myocardial infarction, congestive heart failure, unplanned revascularization including target vessel revascularization (TVR), target lesion revascularization (TLR) and Coronary artery bypass graft (CABG).
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The individual components of the primary end-point
Time Frame: 2 Years
Cardiac death (including periprocedural), non-fatal myocardial infarction, congestive heart failure, unplanned revascularization including target vessel revascularization (TVR), target lesion revascularization (TLR) and Coronary artery bypass graft (CABG)
2 Years
Major Bleeding
Time Frame: 2 Years
ACUITY defined major bleeding (Stone et al, 2004)
2 Years
Acute kidney injury (AKI)
Time Frame: 2 Years
a 25% relative or 0.5mg/dL (44.2µmol/L) absolute increase in presenting serum creatinine after PPCI.
2 Years
6 months- 1 year MACE, and its individual components.
Time Frame: 2 Years
Cardiac death (including periprocedural), non-fatal myocardial infarction, congestive heart failure, unplanned revascularization including target vessel revascularization (TVR), target lesion revascularization (TLR) and Coronary artery bypass graft (CABG),and a composite of these components.
2 Years

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Salwa R. Dimitry, MD, Department of Cardiology, Assiut University Faculty of Medicine
  • Study Director: Tarek A. Nagib, MD, Department of Cardiology, Assiut University Faculty of Medicine
  • Study Director: Khaled M. Elmaghraby, MD, Department of Cardiology, Assiut University Faculty of Medicine

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)

July 1, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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