- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933581
A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome (ICON1)
April 5, 2017 updated by: Newcastle-upon-Tyne Hospitals NHS Trust
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Newcastle upon Tyne, United Kingdom, NE77DN
- Freeman Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ICON 1 is a prospective cohort study of older patients presenting with ACS.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ACS undergoing CA and PCI
Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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1 YEAR
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Quality of life SF 36, EQ 5D
Time Frame: 1 YEAR
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1 YEAR
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vijay Kunadian, MD FRCP, Newcastle University and NUTH NHS Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ratcovich H, Beska B, Mills G, Holmvang L, Adams-Hall J, Stevenson H, Veerasamy M, Wilkinson C, Kunadian V. Five-year clinical outcomes in patients with frailty aged >/=75 years with non-ST elevation acute coronary syndrome undergoing invasive management. Eur Heart J Open. 2022 May 16;2(3):oeac035. doi: 10.1093/ehjopen/oeac035. eCollection 2022 May.
- Beska B, Mills GB, Ratcovich H, Wilkinson C, Damluji AA, Kunadian V. Impact of multimorbidity on long-term outcomes in older adults with non-ST elevation acute coronary syndrome in the North East of England: a multi-centre cohort study of patients undergoing invasive care. BMJ Open. 2022 Jul 26;12(7):e061830. doi: 10.1136/bmjopen-2022-061830.
- Beska B, Coakley D, MacGowan G, Adams-Hall J, Wilkinson C, Kunadian V. Frailty and quality of life after invasive management for non-ST elevation acute coronary syndrome. Heart. 2022 Feb;108(3):203-211. doi: 10.1136/heartjnl-2021-319064. Epub 2021 May 14.
- Chan D, Martin-Ruiz C, Saretzki G, Neely D, Qiu W, Kunadian V. The association of telomere length and telomerase activity with adverse outcomes in older patients with non-ST-elevation acute coronary syndrome. PLoS One. 2020 Jan 10;15(1):e0227616. doi: 10.1371/journal.pone.0227616. eCollection 2020.
- Gu SZ, Qiu W, Batty JA, Sinclair H, Veerasamy M, Brugaletta S, Neely D, Ford G, Calvert PA, Mintz GS, Kunadian V. Coronary artery lesion phenotype in frail older patients with non-ST-elevation acute coronary syndrome undergoing invasive care. EuroIntervention. 2019 Jun 12;15(3):e261-e268. doi: 10.4244/EIJ-D-18-00848.
- Gu SZ, Beska B, Chan D, Neely D, Batty JA, Adams-Hall J, Mossop H, Qiu W, Kunadian V. Cognitive Decline in Older Patients With Non- ST Elevation Acute Coronary Syndrome. J Am Heart Assoc. 2019 Feb 19;8(4):e011218. doi: 10.1161/JAHA.118.011218.
- Kunadian V, Neely RD, Sinclair H, Batty JA, Veerasamy M, Ford GA, Qiu W. Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study. BMJ Open. 2016 Aug 23;6(8):e012091. doi: 10.1136/bmjopen-2016-012091.
- Sinclair H, Batty JA, Qiu W, Kunadian V. Engaging older patients in cardiovascular research: observational analysis of the ICON-1 study. Open Heart. 2016 Aug 3;3(2):e000436. doi: 10.1136/openhrt-2016-000436. eCollection 2016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 28, 2013
First Submitted That Met QC Criteria
August 28, 2013
First Posted (Estimate)
September 2, 2013
Study Record Updates
Last Update Posted (Actual)
April 6, 2017
Last Update Submitted That Met QC Criteria
April 5, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12742
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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