A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— ICON1  

Official title:

ICON1: A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933581
• Other study ID #: 12742
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: April 5, 2017
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronary artery disease and heart attacks are the leading cause of death in the UK. Our population is ageing. The number of older patients suffering heart attacks and having angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty, older patients (80 years of age or over) are at 5 times increased risk of death at one year compared to their predicted normal life expectancy. In addition, many patients present with further heart attacks, stroke and undergo repeat heart catheter test and angioplasty procedures. At present it is not clear who will or will not experience further problems in the future. The ability to predict who will and will not suffer future problems at the time of initial presentation can be helpful in providing additional treatment and close monitoring to those that are at risk of further problems. The ICON 1 study is set out to study just that. In this study, older patients will undergo a comprehensive evaluation of the cardiovascular disease burden by undergoing additional investigations. These results from each patient will be used to develop a risk score that will inform physicians of the patient's future risk of developing adverse events and provide a better understanding of how to manage older patients with coronary artery disease and also help plan future studies looking at treatment strategies that might be beneficial in improving outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion criteria: Older patients (65+) presenting with ACS for coronary angiography will be recruited into this study.

Exclusion criteria: Those presenting with cardiogenic shock, those with co-existing malignancy with life expectancy less than one year and those with evidence of active infection such as urinary tract infection, pneumonia, sepsis and any wound infection will also be excluded from the study.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
United Kingdom	Freeman Hospital	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome: occurrence of one or more of death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding		1 YEAR
Secondary	Quality of life SF 36, EQ 5D		1 YEAR