Age-Dependent Impact of the SYNTAX-score on Mortality

Age-Dependent Impact of the SYNTAX-score on Mortality After Percutaneous Coronary Intervention in an All-Comer Population

The SYNTAX-score has been proposed as a tool for risk stratification and guiding revascularization therapy in patients with complex coronary artery disease.

There are limited data on the prognostic value of the SYNTAX-score among elderly patients.

Aim of this study was to investigate whether age modifies the impact of the SYNTAX-score on all-cause mortality at 2 years after percutaneous coronary intervention (PCI).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; PCI
• Intervention / Treatment: Procedure: PCI

Detailed Description

SYNTAX score has been used as a tool to quantify severity of coronary artery disease. Interventional or operative treatment of patients is associated with improvement in SYTAX score after PCI so called residual SYNTAX score. The higher the SYNTAX score value the higher is the mortality. Whereas this is true for both young and old patients is debatable. Therefore we aim to investigate in this registry age-dependent impact of baseline and residual SYNTAX score on 1- and 2-year mortality after PCI

• Study Type: Observational
• Enrollment (Actual): 1331

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 812377
    • Ludwig-Maximilians University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All-comer population undergoing PCI

Description

Inclusion Criteria:

• patients undergoing PCI at our center

Exclusion Criteria:

• prior coronary artery bypass grafting
• no PCI

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing PCI; all-comer population undergoing PCI	Procedure: PCI; treatment of coronary arteries and evaluation of SYNTAX score pre and post (to quantify severity of disease); Other Names: percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medium- to long-term Mortality	Overall mortality	2 years

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Julinda Mehilli, MD, LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): March 31, 2014
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: SYNTAX score, PCI, elderly
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: GEMucI003-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No