Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2016 Aug 23;6(8):e012091.
doi: 10.1136/bmjopen-2016-012091.

Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study

Vijay Kunadian  1 , R Dermot G Neely  2 , Hannah Sinclair  1 , Jonathan A Batty  1 , Murugapathy Veerasamy  1 , Gary A Ford  3 , Weiliang Qiu  4
Affiliations
Observational Study

Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study

Vijay Kunadian et al. BMJ Open. .

Abstract

Introduction: The ICON1 study (a study to Improve Cardiovascular Outcomes in high-risk older patieNts with acute coronary syndrome) is a prospective observational study of older patients (≥75 years old) with non-ST-elevation acute coronary syndrome managed by contemporary treatment (pharmacological and invasive). The aim of the study was to determine the predictors of poor cardiovascular outcomes in this age group and to generate a risk prediction tool.

Methods and analysis: Participants are recruited from 2 tertiary hospitals in the UK. Baseline evaluation includes frailty, comorbidity, cognition and quality-of-life measures, inflammatory status assessed by a biomarker panel, including microRNAs, senescence assessed by telomere length and telomerase activity, cardiovascular status assessed by arterial stiffness, endothelial function, carotid intima media thickness and left ventricular systolic and diastolic function, and coronary plaque assessed by virtual histology intravascular ultrasound and optical coherence tomography. The patients are followed-up at 30 days and at 1 year for primary outcome measures of death, myocardial infarction, stroke, unplanned revascularisation, bleeding and rehospitalisation.

Ethics and dissemination: The study has been approved by the regional ethics committee (REC 12/NE/016). Findings of the study will be presented in scientific sessions and will be published in peer-reviewed journals.

Trial registration number: NCT01933581: Pre-results.

Keywords: Study design; acute coronary syndrome; older patients.

PubMed Disclaimer

Figures

Figure 1
Figure 1
ICON1 study flow chart. CCS, Canadian Cardiovascular Society; ICON1, Improve Cardiovascular Outcomes in high-risk older patieNts with acute coronary syndrome; MoCA, Montreal Cognitive Assessment; NSTEMI, non-ST-elevation acute coronary syndrome; NYHA, New York Heart Association; OCT, optical coherence tomography; PCI, percutaneous coronary intervention; UA, unstable angina; VH-IVUS, virtual histology—intravascular ultrasound.
Figure 2
Figure 2
Decision tree for lesion classification on VH-IVUS, virtual histology—intravascular ultrasound (VH-IVUS) with image examples. Adapted from García-García et al.
Figure 3
Figure 3
Study power. A plot of power versus hazard ratios for the sample size of 300 patients and 1-year mortality rates.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet 1997;349:1269–76. 10.1016/S0140-6736(96)07493-4 - DOI - PubMed
    1. Finegold JA, Asaria P, Francis DP. Mortality from ischaemic heart disease by country, region, and age: statistics from World Health Organisation and United Nations. Int J Cardiol 2013;168:934–45. 10.1016/j.ijcard.2012.10.046 - DOI - PMC - PubMed
    1. Townsend N, Wickramasinghe K, Bhatnagar P et al. . Coronary heart disease statistics 2012 edition. London: British Heart Foundation, 2012.
    1. Gavalova L, Weston C. Myocardial Ischaemia National Audit Project Annual Public Report April 2012–March 2013. London: National Institute for Cardiovascular Outcomes Research, 2013.
    1. Veerasamy M, Edwards R, Ford G et al. . Acute coronary syndrome among older patients: a review. Cardiol Rev 2015;23:26–32. 10.1097/CRD.0000000000000016 - DOI - PubMed

Publication types

Associated data

LinkOut - more resources