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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01933581
First received: August 28, 2013
Last updated: March 22, 2016
Last verified: March 2016

August 28, 2013
March 22, 2016
October 2012
December 2016   (final data collection date for primary outcome measure)
Composite outcome: occurrence of one or more of death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
Death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01933581 on ClinicalTrials.gov Archive Site
Quality of life SF 36, EQ 5D [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome
ICON1: A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
PBMCs
Probability Sample
ICON 1 is a prospective cohort study of older patients presenting with ACS.
Acute Coronary Syndrome
Not Provided
ACS undergoing CA and PCI
Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2016
December 2016   (final data collection date for primary outcome measure)

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.

Both
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01933581
12742
No
Not Provided
Not Provided
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Not Provided
Principal Investigator: Vijay Kunadian, MD FRCP Newcastle University and NUTH NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP