An interventional study of Coronary function testing and Percutaneous coronary intervention in Coronary Artery Disease (CAD), Obstructive Coronary Artery Disease and Coronary Microvascular Dysfunction (CMD), sponsored by UMC Utrecht. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Diagnostic
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:
Exclusion Criteria:
Standard care arm, in which participants will receive their percutaneous coronary intervention (PCI) according to local practice standards and guidelines
Procedure: Percutaneous coronary intervention
In the intervention group, participants will receive coronary function testing (CFT) before and after their percutaneous coronary intervention to test for coronary microvascular dysfunction and coronary vasospasm
Diagnostic Test: Coronary function testing · Procedure: Percutaneous coronary intervention
Coronary function testing to test for coronary microvascular dysfunction and coronary vasospasm
Also known as: CFT
Percutaneous coronary intervention performed according to local practice standards and guidelines
Also known as: PCI
Angina symptom burden
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.
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Seattle Angina Questionnaire Summary Score (SAQSS)
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.
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Canadian Cardiovascular Society (CCS) grading of angina pectoris
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).
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Seattle Angina Questionnaire (SAQ)
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.
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L)
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.
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Patient Global Impression of Change (PGI-C)
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).
Time frame: At 6 and 12 months of follow-up (after procedure)
Prevalence coronary vasomotor disorders
Prevalence of individual coronary vasomotor disorder endotypes in the intervention arm.
Time frame: From baseline to 12 months of follow-up (after procedure)
Disease endotype
Impact of disease endotype on the between-group difference in clinical response to percutaneous coronary intervention.
Time frame: From baseline to 12 months of follow-up (after procedure)
Role coronary computed tomography angiography (CCTA)
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.
Time frame: From baseline to 12 months of follow-up (after procedure)
Role of biomarkers
Relationship of biomarker levels and the presence of coronary vasomotor dysfunction.
Time frame: From baseline to 12 months of follow-up (after procedure)
Adverse events
Adverse clinical events: Hospital admission for angina pectoris, acute coronary syndrome, unscheduled (repeat) coronary angiography, (cardiac) death.
Time frame: From baseline to 12 months of follow-up (after procedure)
Similarity score
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.
Time frame: From baseline to 12 months of follow-up (after procedure)
Difference MacNew score
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.
Time frame: From baseline to 6 months of follow-up (after procedure)
Canadian Cardiovascular Society (CCS) grading of angina pectoris at 12 months
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).
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
Seattle Angina Questionnaire (SAQ) at 12 months
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.
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
Seattle Angina Questtionaire Summary Score (SAQSS) at 12 months
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.
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L) at 12 months
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.
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
MacNew at 12 months
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.
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
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