Coronary Artery Disease (CAD), Coronary Microvascular Dysfunction (CMD), Obstructive Coronary Artery Disease, Stable Angina Pectoris, Vasospasm, Coronary
Conditions
Keywords
Coronary Function Testing, Percutaneous Coronary Intervention, Stable Angina
Brief summary
The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is: Does performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life? Researchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention. Participants will: * Undergo percutaneous coronary intervention and coronary function testing in the intervention arm * Undergo percutaneous coronary intervention in the control arm
Interventions
DIAGNOSTIC_TESTCoronary function testing
Coronary function testing to test for coronary microvascular dysfunction and coronary vasospasm
PROCEDUREPercutaneous coronary intervention
Percutaneous coronary intervention performed according to local practice standards and guidelines
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years of age * 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
* Prior coronary artery bypass graft surgery. * Stenosis \>90% in the target vessel or a stenosis deemed unsafe for pressure wire instrumentation * Known severe left ventricular dysfunction (left ventricular ejection fraction by any imaging modality) * Severe valvular disease * Renal impairment (estimated glomerular filtration rate \<30mL/min) * Contra-indications for the use of adenosine or acetylcholine * Expected inability to conform to the clinical follow-up * Unable or unwilling to use the ORBITA-app * Life expectancy of less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angina symptom burden | From baseline to 6 months of follow-up (after procedure) | The difference in the change in angina symptom score between groups from baseline to 6-month follow-up. Patients will keep track of their symptoms daily during which they can answer the question if they had symptoms with 'yes' or 'no'. If 'yes' is selected, they can select how frequent their attacks were on that day (from 0-10, were 0 = no attack and 10 = 10 or more attacks) and also the severity of the attacks (mild, moderate or severe). A higher score means a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Seattle Angina Questionnaire Summary Score (SAQSS) | From baseline to 6 months of follow-up (after procedure) | The mean difference in the within-subject change in Seattle Angina Questionnaire Summary Score (SAQSS) between the groups from baseline to 6-month follow-up. The score ranges from 0-100, where a higher score means a better outcome. |
| Difference Canadian Cardiovascular Society (CCS) grading of angina pectoris | From baseline to 6 months of follow-up (after procedure) | Between-group difference in angina severity as assessed by the Canadian Cardiovascular Society class at 6-month follow-up and its change from baseline to 6-month follow-up. There are four classes: I, II, III and IV. A higher class means a higher angina/symptom burden (worse outcome). |
| Difference Seattle Angina Questionnaire (SAQ) | From baseline to 6 months of follow-up (after procedure) | Between-group difference in physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire (SAQ) at 6-month follow-up, and their change from baseline to 6-month follow-up. The subscales are all transformed to a scale from 0-100, where a higher score means a better outcome. |
| Difference EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L) | From baseline to 6 months of follow-up (after procedure) | Between-group difference in quality of life as assessed with the EQ-5D-5L quality of life questionnaire at 6-month follow-up, and their change from baseline to 6-month follow-up. There are 5 domains with 5 levels, in which the scores are transformed to values ranging from -0,109 to 1,000. The EQ-5D-5L Visual Analog Scale (VAS) score, as part of the questionnaire, ranges from 0-100. In both cases a higher score means a better outcome. |
| Difference Patient Global Impression of Change (PGI-C) | At 6 and 12 months of follow-up (after procedure) | Patient Global Impression of Change (PGI-C) Score: at 6-, and 12-months post-procedure. The score ranges from 1-7, where a lower score means (better) improvement and higher scores means no improvement/worsening (worse outcome). |
| Prevalence coronary vasomotor disorders | From baseline to 12 months of follow-up (after procedure) | Prevalence of individual coronary vasomotor disorder endotypes in the intervention arm. |
| Disease endotype | From baseline to 12 months of follow-up (after procedure) | Impact of disease endotype on the between-group difference in clinical response to percutaneous coronary intervention. |
| Role coronary computed tomography angiography (CCTA) | From baseline to 12 months of follow-up (after procedure) | Relationship of coronary computed tomography angiography (CCTA) parameters (collected from patients from whom images are available) with hemodynamic relevance of coronary stenosis and the presence of coronary vasomotor disorders. |
| Role of biomarkers | From baseline to 12 months of follow-up (after procedure) | Relationship of biomarker levels and the presence of coronary vasomotor dysfunction. |
| Adverse events | From baseline to 12 months of follow-up (after procedure) | Adverse clinical events: Hospital admission for angina pectoris, acute coronary syndrome, unscheduled (repeat) coronary angiography, (cardiac) death. |
| Similarity score | From baseline to 12 months of follow-up (after procedure) | Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery, and during coronary function testing in the CFT-guided (intervention) arm, and its relationship with change in angina symptom score after revascularization. The similarity score ranges from 0-10, where 0 means patient has no (recognizable) complaints and 10 means patient experiences exactly the same pain as usual. |
| Difference MacNew score | From baseline to 6 months of follow-up (after procedure) | Between-group difference in quality of life as assessed with the MacNew quality of life questionnaire at 6-month follow-up. There are several items, which are scored from 1-7. Domain scores and global scores are calculated using the average scores of these items (so also from 1-7). A higher score means a better outcome. |
| Canadian Cardiovascular Society (CCS) grading of angina pectoris at 12 months | From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure) | Change in CCS class from 6-months to 12-months and from baseline to 12-months. There are four classes: I, II, III and IV. A higher class means a higher angina/symptom burden (worse outcome). |
| Seattle Angina Questionnaire (SAQ) at 12 months | From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure) | Change in SAQ from 6-months to 12-months and from baseline to 12-months. The subscales are all transformed to a scale from 0-100, where a higher score means a better outcome. |
| Seattle Angina Questtionaire Summary Score (SAQSS) at 12 months | From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure) | Change in SAQSS from 6-months to 12-months and from baseline to 12-months. The score ranges from 0-100, where a higher score means a better outcome. |
| EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L) at 12 months | From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure) | Change in EQ-5D-5L from 6-months to 12-months and from baseline to 12-months. There are 5 domains with 5 levels, in which the scores are transformed to values ranging from -0,109 to 1,000. The EQ-5D-5L Visual Analog Scale (VAS) score, as part of the questionnaire, ranges from 0-100. In both cases a higher score means a better outcome. |
| MacNew at 12 months | From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure) | Change in MacNew from 6-months to 12-months and from baseline to 12-months. There are several items, which are scored from 1-7. Domain scores and global scores are calculated using the average scores of these items (so also from 1-7). A higher score means a better outcome. |
Outcome results
None listed