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

NCT ID: NCT01933581

Last Updated: 2017-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACS undergoing CA and PCI

Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vijay Kunadian, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Newcastle University and NUTH NHS Trust

Locations

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Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 39076483 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38761976 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38436050 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37813562 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35919345 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35882457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33990413 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31923255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30777840 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30773118 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27554105 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27547431 (View on PubMed)

Other Identifiers

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12742

Identifier Type: -

Identifier Source: org_study_id

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