A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome (ICON1)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
First received: August 28, 2013
Last updated: August 31, 2013
Last verified: August 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||ICON1: A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Quality of life SF 36, EQ 5D [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
ACS undergoing CA and PCI
Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI
|Ages Eligible for Study:
||65 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
ICON 1 is a prospective cohort study of older patients presenting with ACS.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933581
|Newcastle upon Tyne, United Kingdom, NE77DN |
|Contact: Vijay Kunadian, MD FRCP |
|Principal Investigator: Vijay Kunadian, MD FRCP |
Newcastle-upon-Tyne Hospitals NHS Trust
||Vijay Kunadian, MD FRCP
||Newcastle University and NUTH NHS Trust
No publications provided
||Newcastle-upon-Tyne Hospitals NHS Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 28, 2013
||August 31, 2013
||United Kingdom: Research Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 02, 2015
Acute Coronary Syndrome
Signs and Symptoms