Barts Sex-CAD Database - Sex Hormones and Inflammatory Status in Coronary Artery Disease

NCT06327984 | Recruiting

• 1 other identifier: 157354
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes'). Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area. Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. The investigators think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood. In this study the investigators wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. The investigators will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. The investigators will combine this data with the data that is routinely collected during hospital admission. In this way the investigators hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research the investigators will address an under researched area and find new ways of treating women and men with coronary artery disease.

Conditions

Coronary Artery Disease; Myocardial Infarction; Acute Coronary Syndrome; Atherosclerosis; Inflammation

Keywords

Coronary artery disease; Acute coronary syndrome; Myocardial infarction; Sex characteristics; Hormones; Inflammation

Outcome Measures

Primary Outcomes (3)

• Mortality

  Mortality at 30 days,1 year and 5 years, and relation to sex hormone/menstrual status/inflammatory profile

  30 days/1 year/5 years

• Re-admission

  Re-admission rates post revascularization and relation to sex hormone/menstrual status/inflammatory profile

  30 days/1 year/5 years

• MACE

  MACE post revascularisation and relation to sex hormone/menstrual status/inflammatory profile

  30 days/1 year/5 years

Secondary Outcomes (2)

• Relationship with specific MI types

  30 days/1 year/5 years

• Relationship with inflammation

  30 days/1 year/5 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients attending Barts Heart Centre with chest pain

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

RECRUITING

Related Publications (3)

• Lee MT, Mahtta D, Ramsey DJ, Liu J, Misra A, Nasir K, Samad Z, Itchhaporia D, Khan SU, Schofield RS, Ballantyne CM, Petersen LA, Virani SS. Sex-Related Disparities in Cardiovascular Health Care Among Patients With Premature Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2021 Jul 1;6(7):782-790. doi: 10.1001/jamacardio.2021.0683.

  PMID: 33881448 BACKGROUND

• Shabbir A, Rathod KS, Khambata RS, Ahluwalia A. Sex Differences in the Inflammatory Response: Pharmacological Opportunities for Therapeutics for Coronary Artery Disease. Annu Rev Pharmacol Toxicol. 2021 Jan 6;61:333-359. doi: 10.1146/annurev-pharmtox-010919-023229. Epub 2020 Oct 9.

  PMID: 33035428 BACKGROUND

• Rathod KS, Jones DA, Jain AK, Lim P, MacCarthy PA, Rakhit R, Lockie T, Kalra S, Dalby MC, Malik IS, Whitbread M, Firoozi S, Bogle R, Redwood S, Cooper J, Gupta A, Lansky A, Wragg A, Mathur A, Ahluwalia A. The influence of biological age and sex on long-term outcome after percutaneous coronary intervention for ST-elevation myocardial infarction. Am J Cardiovasc Dis. 2021 Oct 25;11(5):659-678. eCollection 2021.

  PMID: 34849299 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples from human blood

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Acute Coronary Syndrome; Atherosclerosis; Inflammation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Krishnaraj Rathod, MBBS PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krishnaraj Rathod, MBBS PhD

CONTACT

020 7882 5720; k.s.rathod@qmul.ac.uk

Amrita Ahluwalia, BSc PhD

CONTACT

020 7882 5720; a.ahluwalia@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: November 21, 2023
• Primary Completion (Estimated): January 31, 2033
• Study Completion (Estimated): January 31, 2033
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

GB (1)