Post-spontaneous coronary artery dissection (SCAD) chest pain Circulatory System
Conditions
Interventions
This pilot study is a randomised, double-blind, placebo-controlled trial investigating the feasibility, safety, and potential efficacy of hormone replacement therapy (bi-HRT) in peri- and post-menopau
Sponsors
University of Leicester
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age =45 years 2. Confirmed as peri- (from the time of onset of first menstrual irregularity) or post-menopausal (12-consecutive months without a menstrual period) 3. Confirmed previous SCAD on invasive angiography in the 3 years prior to screening 4. Symptomatic chest pain occurring on at least 4 days in the previous 1-month 5. Able to understand written English
Exclusion criteria
Exclusion criteria: 1. History of heart failure 2. History of stroke or TIA 3. Previous or known thromboembolic diseases or disorders 4. Previous breast cancer or a family history of breast cancer (1st degree relatives) 5. Recorded allergies to soya or peanut, the trial investigational medical products or excipients 6. Previous endometrial or ovarian cancer 7. Requiring hormonal contraception 8. Has a Mirena coil in situ, or has had a previous hysterectomy 9. Childbirth in the last 12-months and/or breastfeeding at the time of screening 10. Taking HRT in the past 6-months 11. Currently or have in the last 1 month taken another IMP 12. Unable to provide fully informed consent 13. Undiagnosed genital bleeding 14. Untreated endometrial hyperplasia 15. Acute liver disease or a history of liver disease. 16. Any other significant healthcare issue deemed by the research team to have a potential impact on trial outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following endpoints will be captured at the trial visits relevant to the outcome measure, e.g., baseline (pre-randomisation), 3, 6 and 12 months: 1. Patient eligibility, recruitment and retention, measured using screening logs, randomisation lists and follow-up completion in the electronic case report form (eCRF) via the numbers screened, randomised, withdrawn from the trial and the reasons for trial withdrawal 2. Patient willingness to be consented and adherence to randomised trial treatment, measured using screening logs, randomisation lists, and discontinuation/completion data collected in the eCRF via the numbers withdrawn from the study trial medication and the reasons for trial medication withdrawal 3. Patient acceptability of randomisation and research visits/data collection measured using data completion in the eCRF 4. Completeness of data collection for patient efficacy outcomes throughout the trial [measured using a data source] 5. Compliance and adherence to trial treatment will mostly be measured using patient-reported compliance and adherence, and also via blood and serum measurements of oestrogen hormones and progesterone and hormone metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcomes will be assessed at baseline, 3, 6 and 12 months: 1. Post-SCAD chest pain measured using the Seattle Angina Questionnaire-7 (SAQ-7) 2. Quality of life measured using the Patient Health Questionnaire-9 (PHQ-9), self-reported quality of life using the EQ-5D-5L questionnaire, general self-efficacy scale for psychological assessment, Generalised Anxiety Disorder Assessment (GAD-7), Cardiac Anxiety Questionnaire (CAQ) and Warwick Edinburgh mental wellbeing scale 3. Non-menopausal ‘cardiac’ symptoms (breathlessness, palpitations) measured using data captured via the Orbita app. 4. Hospital admission, adjudicated as MACCE (death, recurrent acute myocardial infarction, recurrent SCAD, revascularisation and stroke), post-SCAD cardiac symptoms and unrelated (including non-MACCE vascular events) by the Data Safety and Monitoring Committee (DSMC), measured using data collected from patient electronic medical records in the eCRF at one timepoint 5. Menopausal symptom severity and frequency measured using a standard, tailored Menopause Symptom Questionnaire 6. Use, or changes in doses, of medications and non-hormonal treatments for menopausal symptoms measured using data collected at follow-up visits in the eCRF at one timepoint Safety outcomes will be measured using data collected from patient electronic medical records and self-reported by the participant at 3, 6 and 12 months: 1. Hospital admission, adjudicated as MACCE (death, recurrent acute myocardial infarction, recurrent SCAD, revascularisation and stroke), post-SCAD cardiac symptoms or unrelated (including non-MACCE vascular events) 2. MACCE events 3. New onset breast cancer, endometrial or ovarian cancer 4. Non-fatal thromboembolism 5. Non-MACCE vascular events | — |
Countries
England, United Kingdom
Outcome results
None listed