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

• Published in: BMJ open 2016-08, Vol.6 (8), p.e012091-e012091
• Main Authors: Kunadian, Vijay, Neely, R Dermot G, Sinclair, Hannah, Batty, Jonathan A, Veerasamy, Murugapathy, Ford, Gary A, Qiu, Weiliang
• Format: Article
• Language: English
• Subjects: Acute Coronary Syndrome - diagnostic imaging; Acute Coronary Syndrome - mortality; Acute Coronary Syndrome - therapy; Acute coronary syndromes; Aged; Aged, 80 and over; Biomarkers - blood; Cardiovascular disease; Cardiovascular Medicine; Comorbidity; England; Frailty; Frailty - diagnosis; Humans; Medical imaging; Mortality; Proportional Hazards Models; Prospective Studies; Quality of Life; Research Design; Risk Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-012091

IntroductionThe 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 analysisParticipants 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 disseminationThe 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 numberNCT01933581: Pre-results.