Coronary microvascular disease Circulatory System Ischaemic heart disease
Conditions
Interventions
Current interventions as of 22/05/2023:
Patients will be recruited from the catheter laboratory protocol or if they have already had invasive coronary physiology assessment previously. On their first
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All adult patients attending for diagnostic coronary angiography for stable angina at St. Thomas’ Hospital who are found to have unobstructed coronary arteries (epicardial coronary artery stenosis < 30% and/or pressure wire negative stenosis). 2. Tertiary referrals for invasive microvascular assessment of patients with angina and established unobstructed coronary arteries.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/05/2023: 1. Patients who are unable or unwilling to consent 2. Contraindications to adenosine 3. Contraindications to amlodipine and/or ranolazine 4. Patients who are already taking the study medications for clinical reasons and are unable to stop them 5. Presence of more than moderate valve disease 6. Previous percutaneous coronary intervention or bypass surgery 7. Known structural heart disease (e.g. cardiomyopathy or congenital heart disease) 8. Pregnant or breastfeeding females 9. Patients who are unable to exercise on a treadmill or those who can exercise for >540 seconds in the absence of any revealed cardiac symptoms on baseline exercise test Previous exclusion criteria: 1. Patients who are unable or unwilling to consent 2. Contraindications to adenosine or acetylcholine (for the catheter laboratory protocol), or amlodipine or ranolazine (for the exercise protocol) 3. Presence of more than moderate valve disease 4. Previous stenting or bypass surgery 5. Heart failure with reduced ejection fraction (LVEF540seconds in men and >480seconds in women) will be excluded from the exercise protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/05/2023: Change in exercise time (in seconds) compared with baseline, measured using an exercise treadmill test at visit 2, visit 3 and visit 4 Previous primary outcome measure: 1. Coronary blood flow will be measured during the coronary angiogram on visit 1 2. Exercise ability will be measured as exercise duration on a treadmill on visits 3 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/05/2023: Change in angina-specific quality of life compared with baseline, measured using the Seattle Angina Questionnaire (SAQ) Summary Score at visit 2, visit 3 and visit 4 Previous secondary outcome measures: Measured at visits 3 and 4: 1. Health-related quality of life measured using The Seattle Angina Questionnaire 2. Step count measured on a pedometer 3. Cardiac biomarkers (high sensitivity troponin T) measured using blood test | — |
Countries
England, United Kingdom
Outcome results
None listed