Angina, Stable, Coronary Artery Disease
Conditions
Brief summary
The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.
Interventions
PROCEDUREPercutaneous coronary intervention
Coronary artery stenting for stable angina
Sponsors
Imperial College Healthcare NHS Trust
Mid and South Essex NHS Foundation Trust
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Angina or angina-equivalent symptoms 2. Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis 3. Referred for percutaneous coronary intervention for treatment of stable angina
Exclusion criteria
1. Age younger than 18 2. Age older than 85 3. Recent acute coronary syndrome 4. Multivessel coronary artery disease 5. Previous coronary artery bypass graft surgery 6. Significant left main stem coronary disease 7. Chronic total occlusion in the target vessel 8. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation 9. Contraindication to antiplatelet therapy 10. Contraindication to adenosine infusion 11. Severe valvular disease 12. Severe LV systolic impairment 13. Severe respiratory disease 14. Life expectancy less than 2 years, pregnancy, unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery | 30 Days | Similarity Score (1-10) (Higher Score = Better Outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in treadmill exercise time | 30 Days | — |
| Change in treadmill time to chest pain | 30 Days | — |
| Angina severity as assessed by Canadian Cardiovascular Society Class | 30 Days | Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome) |
| Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire. | 30 Days | Seattle Angina Questionnaire, (Lower Score = Better Outcome) |
| Change in angina symptom score | 30 Days | Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome) |
| Change in dobutamine stress echocardiography score | 30 Days | (Lower Score = Better Outcome) |
| Need for anti-anginal medication introduction and uptitration | 30 Days | — |
| Anxiety as assessed by the GAD-7 Score | 30 days | Generalised anxiety and depression - 7 Score. (Lower Score = Better Outcome) |
| Depression as assessed by the PHQ-9 Score | 30 days | Patient Health Questionnaire - 9. (Lower Score = Better Outcome) |
| Quality of Life assessed with the EQ-5D-5L questionnaire | 30 Days | (Lower Score = Better Outcome) |
Countries
United Kingdom
Outcome results
None listed