coronary microvascular dysfunction (CMD)
Conditions
Interventions
Performing coronary function test in combination with the percutaneous coronary intervention vs. performing percutaneous coronary intervention alone. The intervention is a CFT-guided stepwise medical
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients >18 years of age2. Hemodynamically relevant obstructive coronary artery disease (as assessed by pressure wire evaluation) in the left anterior descending coronary artery amenable to percutaneous coronary intervention at the discretion of the operator.
Exclusion criteria
Exclusion criteria: 1. Prior coronary artery bypass graft surgery.2. Stenosis >90% in the target vessel or a stenosis deemed unsafe for pressure wire instrumentation.3. Known severe left ventricular dysfunction (left ventricular ejection fraction <30% byany imaging modality)4. Severe valvular disease5. Renal impairment (estimated glomerular filtration rate <30mL/min)6. Contra-indications for the use of adenosine or acetylcholine7. Expected inability to conform to the clinical follow-up8. Unable or unwilling to use the ORBITA-app9. Life expectancy of less than 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The difference in the change in angina symptom score between groups from baseline to 6-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The mean difference in the within-subject change in SAQ Summary Score (SAQSS) between the groups from baseline to 6-month follow-up. 2. Between-group difference in angina severity as assessed by Canadian Cardiovascular Society class at 6-month follow-up and its change from baseline to 6-month follow-up. 3. Between-group difference in physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire at 6-month follow-up, and their change from baseline to 6-month follow-up. 4. Between-group difference in quality of life as assessed with the EQ-5D-5L and MacNew quality of life questionnaires at 6-month follow-up, and their change from baseline to 6-month follow-up. 5. Patient Global Impression of Change (PGI-C) Score: at 6-, and 12-months post-procedure. 6. Prevalence of individual coronary vasomotor disorder endotypes in the intervention arm. 7. Impact of disease endotype on the between-group difference in clinical response to PCI. 8. Relationship of coronary computed tomography angiography parameters (collected from patients from whom images are available) with hemodynamic relevance of coronary stenosis and the presence of coronary vasomotor disorders. 9. Relationship of biomarker levels and the presence of coronary vasomotor dysfunction. 10. Adverse clinical events: Hospital admission for angina pectoris, acute coronary syndrome, unscheduled (repeat) coronary angiography, (cardiac) death. 11. Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery, and during coronary function testing in the CFT-guided arm, and its relationship with change in angina symptom score after revascularization. 12. .Change in CCS class and Quality of Life using the SAQ (Summary score and all individual domains), EQ-5D-5L, MacNew from 6-months to 12-months and from baseline to 12-months. | — |
Countries
Germany, Italy, Netherlands
Contacts
Public ContactT.P. van de Hoef
Universitair Medisch Centrum Utrecht
Outcome results
None listed