A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome
ICON1
ICON1: A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Longer than P75 for all trials
1 active site
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
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2013
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 6, 2017
April 1, 2017
4.2 years
August 28, 2013
April 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Composite outcome: occurrence of one or more of death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding
1 YEAR
Secondary Outcomes (1)
Quality of life SF 36, EQ 5D
1 YEAR
Study Arms (1)
ACS undergoing CA and PCI
Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI
Eligibility Criteria
ICON 1 is a prospective cohort study of older patients presenting with ACS.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Freeman Hospital
Newcastle upon Tyne, NE77DN, United Kingdom
Related Publications (12)
Rubino F, Brugaletta S, Mills G, Pompei G, Scarsini R, Ribichini F, Raber L, Kunadian V. Coronary Artery Plaque Phenotype and 5-Year Clinical Outcomes in Older Patients with Non-ST Elevation Acute Coronary Syndrome. Rev Cardiovasc Med. 2024 May 14;25(5):168. doi: 10.31083/j.rcm2505168. eCollection 2024 May.
PMID: 39076483DERIVEDDirjayanto VJ, Martin-Ruiz C, Pompei G, Rubino F, Kunadian V. The association of inflammatory biomarkers and long-term clinical outcomes in older adults with non-ST elevation acute coronary syndrome. Int J Cardiol. 2024 Aug 15;409:132177. doi: 10.1016/j.ijcard.2024.132177. Epub 2024 May 16.
PMID: 38761976DERIVEDDirjayanto VJ, Pompei G, Rubino F, Biscaglia S, Campo G, Mihailidou AS, den Ruijter H, Kunadian V. Non-invasive vascular measures as prognostic predictors for older patients with non-ST elevation acute coronary syndrome. Coron Artery Dis. 2024 Aug 1;35(5):368-381. doi: 10.1097/MCA.0000000000001352. Epub 2024 Mar 4.
PMID: 38436050DERIVEDDirjayanto VJ, Alkhalil M, Dodson J, Mills G, Pompei G, Rubino F, Kunadian V. Cognitive impairment and outcomes in older adults with non-ST-elevation acute coronary syndrome. Heart. 2024 Feb 23;110(6):416-424. doi: 10.1136/heartjnl-2023-323224.
PMID: 37813562DERIVEDRatcovich 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.
PMID: 35919345DERIVEDBeska 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.
PMID: 35882457DERIVEDBeska 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.
PMID: 33990413DERIVEDChan 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.
PMID: 31923255DERIVEDGu 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.
PMID: 30777840DERIVEDGu 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.
PMID: 30773118DERIVEDKunadian 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.
PMID: 27554105DERIVEDSinclair 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.
PMID: 27547431DERIVED
Biospecimen
PBMCs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vijay Kunadian, MD FRCP
Newcastle University and NUTH NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2013
First Posted
September 2, 2013
Study Start
October 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
April 6, 2017
Record last verified: 2017-04