NCT03479840

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

March 20, 2018

Last Update Submit

August 7, 2018

Conditions

Coronary Artery DiseasePCI

Keywords

SYNTAX score, PCI, elderly

Outcome Measures

Primary Outcomes (1)

  • Medium- to long-term Mortality

    Overall mortality

    2 years

Study Arms (1)

Patients undergoing PCI

all-comer population undergoing PCI

Procedure: PCI

Interventions

PCIPROCEDURE

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

Also known as: percutaneous coronary intervention
Patients undergoing PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All-comer population undergoing PCI

You may qualify if:

  • patients undergoing PCI at our center

You may not qualify if:

  • prior coronary artery bypass grafting
  • no PCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig-Maximilians University

Munich, 812377, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Julinda Mehilli, MD

    LMU Klinikum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

January 1, 2013

Primary Completion

March 31, 2014

Study Completion

December 31, 2016

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)