Coronary Artery Disease (CAD)NCT07449052
Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease
A study testing Coronary function testing and Percutaneous coronary intervention in people with Coronary Artery Disease (CAD) and Obstructive Coronary Artery Disease, run by UMC Utrecht.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD)
- What is being tested?
- Coronary function testing and Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Expected inability to conform to the clinical follow-up
- Unable or unwilling to use the ORBITA-app
- Life expectancy of less than 12 months.
About this study
Official title: Inclusive Invasive Physiological Assessment in Angina Syndromes - Obstructive Coronary Artery Disease
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?
Read more
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
- Conditions
- Coronary Artery Disease (CAD), Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD), Vasospasm, Coronary, Stable Angina Pectoris
- Being tested
- Coronary function testing, Percutaneous coronary intervention
- Keywords
- Coronary Function Testing, Percutaneous Coronary Intervention, Stable Angina
- Medical subject headings
- Coronary Artery Disease, Coronary Vasospasm, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary function testingDiagnostic test
Also called CFT
Coronary function testing to test for coronary microvascular dysfunction and coronary vasospasm
Percutaneous coronary interventionProcedure or surgery
Also called PCI
Percutaneous coronary intervention performed according to local practice standards and guidelines
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention | Active comparator | Standard care arm, in which participants will receive their percutaneous coronary intervention (PCI) according to local practice standards and guidelines Receives: Procedure: Percutaneous coronary intervention |
| Percutaneous coronary intervention + coronary function testing | Experimental | 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 Receives: Diagnostic Test: Coronary function testing; Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months of follow-up (after procedure)
Secondary outcomes (17)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 12 months of follow-up (after procedure)
Role of biomarkers
Relationship of biomarker levels and the presence of coronary vasomotor dysfunction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim P. van de Hoef, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449052
- Sponsor's protocol ID
- ILIAS OBSTRUCTIVE
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusive Invasive Physiological Assessment in Angina Syndromes - Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07449052
- Acronym / sponsor ID
- ILIAS OBSTRUCTIVE
- Conditions
- Coronary Artery Disease (CAD), Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD), Vasospasm, Coronary, Stable Angina Pectoris
- Keywords
- Coronary Function Testing, Percutaneous Coronary Intervention, Stable Angina
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention | Active comparator | Procedure: Percutaneous coronary interventionStandard care arm, in which participants will receive their percutaneous coronary intervention (PCI) according to local practice standards and guidelines |
| Percutaneous coronary intervention + coronary function testing | Experimental | Diagnostic Test: Coronary function testing, Procedure: Percutaneous coronary interventionIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary function testingAlso: CFTCoronary function testing to test for coronary microvascular dysfunction and coronary vasospasm | Diagnostic test | Percutaneous coronary intervention + coronary function testing |
| Percutaneous coronary interventionAlso: PCIPercutaneous coronary intervention performed according to local practice standards and guidelines | Procedure or surgery | Percutaneous coronary intervention, Percutaneous coronary intervention + coronary function testing |
Primary outcome
Angina symptom burden
Time frame: 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.
17 secondary outcomes
Difference Seattle Angina Questionnaire Summary Score (SAQSS)
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Seattle Angina Questionnaire (SAQ)
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L)
Time frame: From baseline to 6 months of follow-up (after procedure)
Difference Patient Global Impression of Change (PGI-C)
Time frame: At 6 and 12 months of follow-up (after procedure)
Prevalence coronary vasomotor disorders
Time frame: From baseline to 12 months of follow-up (after procedure)
Disease endotype
Time frame: From baseline to 12 months of follow-up (after procedure)
Role coronary computed tomography angiography (CCTA)
Time frame: From baseline to 12 months of follow-up (after procedure)
Role of biomarkers
Time frame: From baseline to 12 months of follow-up (after procedure)
Adverse events
Time frame: From baseline to 12 months of follow-up (after procedure)
Similarity score
Time frame: From baseline to 12 months of follow-up (after procedure)
Difference MacNew score
Time frame: From baseline to 6 months of follow-up (after procedure)
Canadian Cardiovascular Society (CCS) grading of angina pectoris at 12 months
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
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
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
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
MacNew at 12 months
Time frame: From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary function testing and Percutaneous coronary intervention in people with Coronary Artery Disease (CAD) and Obstructive Coronary Artery Disease, run by UMC Utrecht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angina symptom burden (time frame: From baseline to 6 months of follow-up (after procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.