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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03479840
Other study ID # GEMucI003-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2016

Study information

Verified date August 2018
Source Klinikum der Universitaet Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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


Recruitment information / eligibility

Status Completed
Enrollment 1331
Est. completion date December 31, 2016
Est. primary completion date March 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients undergoing PCI at our center

Exclusion Criteria:

- prior coronary artery bypass grafting

- no PCI

Study Design


Intervention

Procedure:
PCI
treatment of coronary arteries and evaluation of SYNTAX score pre and post (to quantify severity of disease)

Locations

Country Name City State
Germany Ludwig-Maximilians University Munich

Sponsors (1)

Lead Sponsor Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medium- to long-term Mortality Overall mortality 2 years
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