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Barts-Sex-CAD

Barts SEX-CAD

Full title: Do female sex hormone levels inform inflammatory status and susceptibility in women suffering coronary artery disease?

Short title: Barts Sex-CAD

Sponsor: Queen Mary University of London (Queen Mary)

Chief Investigator: Dr Krishnaraj Rathod, Senior Clinical Lecturer & Honorary Consultant Cardiologist, Barts Heart Centre, West Smithfield, London, EC1A 7BE

Co-investigators: Dr Andrew John Sullivan Clinical Research Fellow, Barts Heart Centre; Prof Amrita Ahluwalia, Professor of Vascular Pharmacology, Dean for Research, Queen Mary University of London & Director of Barts CVCTU; Prof Anthony Mathur, Professor of Cardiology, Queen Mary University of London & Co-Director for Cardiovascular Research, Barts Health NHS Trust

Contact: a.j.sullivan@qmul.ac.uk

Registration: https://clinicaltrials.gov/study/NCT06327984

Study design: Single-centre observational study

Objective: To assess whether the measurement of sex hormone levels (FSH, LH, oestradiol, progesterone, and testosterone), inflammatory markers, and menstrual status at presentation can support clinical decision-making in patients with suspected coronary artery disease, and inform the development of a precision medicine approach.

Number of participants: 6,000

Study duration: 3 years

Location: Barts Health NHS Trust, St Bartholomew’s Hospital, Barts Heart Centre, London

Summary: This single-centre observational study will explore the relationship between female sex hormone levels, inflammatory status, and susceptibility to coronary artery disease (CAD). The Barts Sex-CAD Database will collect data from approximately 6,000 patients aged 16 and over presenting with chest pain to the Barts Heart Centre. The study will evaluate whether sex hormone profiling (FSH, LH, oestradiol, progesterone, testosterone), assessment of menstrual status, and inflammatory markers can contribute to improved clinical decision-making in women. Patients under 16, those lacking capacity, and individuals whose chest pain is unrelated to CAD (e.g. musculoskeletal or gastrointestinal causes) will be excluded. Comparative analyses will be conducted to assess differences in clinical characteristics, diagnostic accuracy, and outcomes using univariate and multivariate statistical methods. The findings aim to inform a future larger trial testing a precision medicine strategy tailored to sex-specific biological factors in cardiovascular disease.

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