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

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ClinicalTrials.gov Identifier: NCT03138473
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Amr Abdelbadee Abdelhameed Othman, Assiut University

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.

Condition or disease Intervention/treatment
STEMI - ST Elevation Myocardial Infarction Multi Vessel Coronary Artery Disease NSTEMI - Non-ST Segment Elevation MI ACS - Acute Coronary Syndrome Diagnostic Test: Residual SYNTAX Score Diagnostic Test: SYNTAX Revascularization Index

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 (6 months to 1 year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS.

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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of Acute Coronary Syndrome Patients With Multi-Vessel Disease
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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, glomerular filtration rate (GFR) and left ventricular ejection fraction (LVEF), using the formula age/LVEF +1 point for every 10 ml/min/1.73 m2 reduction of GFR below 60 ml/min/1.73 m2 (1 point for GFR between 59 and 50, 2 points for GFR between 49 and 40 and 3 points for GFR between 39 and 30 ml/min/1.73 m2). The GFR 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.




Primary Outcome Measures :
  1. In-hospital major adverse cardiac events (MACE) [ Time Frame: 1 Year ]
    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).


Secondary Outcome Measures :
  1. The individual components of the primary end-point [ Time Frame: 1 Year ]
    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. Major Bleeding [ Time Frame: 1 Year ]
    ACUITY defined major bleeding (Stone et al, 2004)

  3. Acute kidney injury (AKI) [ Time Frame: 1 Year ]
    a 25% relative or 0.5mg/dL (44.2µmol/L) absolute increase in presenting serum creatinine after PPCI.

  4. 6 months- 1 year MACE, and its individual components. [ Time Frame: 1 Year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138473


Contacts
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Contact: Amr A. Othman, MBBCh +201004674109 amr989@gmail.com

Locations
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Egypt
Assiut University Heart Hospital Recruiting
Assiut, Egypt, 71515
Contact: Hosam H. El-Araby, MD       hosam_hasan@aun.edu.eg   
Sponsors and Collaborators
Assiut University
Investigators
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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:
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. Review. Erratum in: J Am Coll Cardiol. 2016 Mar 29;67(12):1506.

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Responsible Party: Amr Abdelbadee Abdelhameed Othman, Resident Physician, Assiut University
ClinicalTrials.gov Identifier: NCT03138473    
Other Study ID Numbers: 17100078
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amr Abdelbadee Abdelhameed Othman, Assiut University:
SYNTAX Score
residual SYNTAX score
SYNTAX Revascularization Index
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases