AzTrials
AzTrials

Acute Coronary SyndromeICON1NCT01933581

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

An observational study of Acute Coronary Syndrome, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Acute Coronary Syndrome
How many people
300 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2012to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Freeman Hospital

    Newcastle upon Tyne, NE77DN

Other trials in United Kingdom

About this study

Official title: 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.

Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01933581
Study groupRoleWhat they receive
ACS undergoing CA and PCIPatients with Acute Coronary Syndrome undergoing coronary angiography and PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome: occurrence of one or more of death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding

    Measured: 1 YEAR

Secondary outcomes (1)

  1. Quality of life SF 36, EQ 5D

    Measured: 1 YEAR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01933581
Sponsor's protocol ID
12742
Acronym
ICON1
Status last verified
Apr 2017
First submitted
28 Aug 2013
Last updated
6 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Magistri M, Collet C, Ribichini FL, Scarsini R, Brugaletta S, Kunadian V. Angiography-derived index of microcirculatory resistance in older patients with acute coronary syndrome undergoing percutaneous coronary intervention. Int J Cardiol. 2026 Sep 25:134945. doi: 10.1016/j.ijcard.2026.134945. Online ahead of print.

    PubMed 42790753

  • 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.

    PubMed 39076483

  • Dirjayanto 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.

    PubMed 38761976

  • Dirjayanto 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.

    PubMed 38436050

  • Dirjayanto 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.

    PubMed 37813562

  • 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.

    PubMed 35919345

  • 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.

    PubMed 35882457

  • 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.

    PubMed 33990413

  • 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.

    PubMed 31923255

  • 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.

    PubMed 30777840

  • 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.

    PubMed 30773118

  • 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.

    PubMed 27554105

  • 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.

    PubMed 27547431

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01933581, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in