Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03138473
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2017-05-01
Brief Title:
Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of ACS Patients With Multi-Vessel Disease
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of Acute Coronary Syndrome Patients With Multi-Vessel Disease
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None