Investigating heart disease in people with haemophilia
The CACHE Study: Coronary Artery Care in HaEmophilia
This study is trying to see how having haemophilia affects the risk of heart disease in men aged 45 and older by using advanced heart imaging techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 45 Years to 120 Years |
| Sex | Male |
| Sponsor | Oxford University Hospitals NHS Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06706206 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between haemophilia and cardiovascular disease using advanced imaging techniques. It focuses on understanding how haemophilia affects the risk of developing heart disease as patients age, particularly in light of improved treatments that have increased life expectancy. The study will involve male participants aged 45 and older with specific levels of Factor VIII or IX deficiency, and will utilize a state-of-the-art photon-counting detector cardiac CT scanner to generate detailed heart images. The findings could provide insights into the unique cardiovascular risks faced by individuals with haemophilia.
Who should consider this trial
Good fit: Ideal candidates are males aged 45 years or older with haemophilia A or B and Factor VIII/IX levels below 40%.
Not a fit: Patients who are unable to provide informed consent or have significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in patients with haemophilia.
How similar studies have performed: While there is limited research specifically on cardiovascular disease in haemophilia, the study's approach using advanced imaging is innovative and could provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be willing and able to give informed consent for participation in the study. * Male, aged 45 years or above (no upper age limit). * Haemophilia A or B with Factor VIII/IX less than 40% (0.40 IU/ml). Exclusion Criteria: * Participants unable or unwilling to give informed consent. * Participants unable to understand the English language. * Participants unable or unwilling to attend for the necessary scans and investigations. * Patients with absolute contra-indications to CT imaging will be excluded from the study. This includes: * Any known contraindications to CT iodinated Contrast. * Significant renal impairment (eGFR \<30 ml/min). * Any other medical conditions which would influence the reliability of the study results determined by the investigators.
Where this trial is running
Oxford, Oxfordshire
- Oxford Haemophilia and Thrombosis Centre, Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Susie Shapiro
- Email: susie.shapiro@ouh.nhs.uk
- Phone: +44 (0)1865 225316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.