Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronary function testing

    Diagnostic test

    Coronary function testing to test for coronary microvascular dysfunction and coronary vasospasm

  • Percutaneous coronary intervention

    Procedure/Surgery

    Percutaneous coronary intervention performed according to local practice standards and guidelines

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Percutaneous coronary interventionActive comparator 1 intervention
Group B: Percutaneous coronary intervention + coronary function testingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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