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:
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 450 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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