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

NCT03138473 | Completed

• 1 other identifier: 17100078
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Multi Vessel Coronary Artery Disease; NSTEMI - Non-ST Segment Elevation MI; ACS - Acute Coronary Syndrome

Keywords

SYNTAX Score; residual SYNTAX score; SYNTAX Revascularization Index

Outcome Measures

Primary Outcomes (1)

• In-hospital major adverse cardiac events (MACE)

  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 Outcomes (4)

• The individual components of the primary end-point

  2 Years

• Major Bleeding

  2 Years

• Acute kidney injury (AKI)

  2 Years

• 6 months- 1 year MACE, and its individual components.

  2 Years

Study Arms (1)

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; Diagnostic Test: SYNTAX Revascularization Index

Interventions

Residual SYNTAX Score DIAGNOSTIC_TEST

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.

Main Group

SYNTAX Revascularization Index DIAGNOSTIC_TEST

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.

Main Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Heart Hospital

Asyut, 71515, Egypt

Location

Related Publications (19)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome

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. Dimitry, MD

  Department of Cardiology, Assiut University Faculty of Medicine

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: July 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)