Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

NCT07449052 | Not Yet Recruiting

• 1 other identifier: ILIAS OBSTRUCTIVE
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

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.

  From baseline to 6 months of follow-up (after procedure)

Secondary Outcomes (17)

• Difference Seattle Angina Questionnaire Summary Score (SAQSS)

  From baseline to 6 months of follow-up (after procedure)

• Difference Canadian Cardiovascular Society (CCS) grading of angina pectoris

  From baseline to 6 months of follow-up (after procedure)

• Difference Seattle Angina Questionnaire (SAQ)

  From baseline to 6 months of follow-up (after procedure)

• Difference EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L)

  From baseline to 6 months of follow-up (after procedure)

• Difference Patient Global Impression of Change (PGI-C)

  At 6 and 12 months of follow-up (after procedure)

Study Arms (2)

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

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

Diagnostic Test: Coronary function testing; Procedure: Percutaneous coronary intervention

Interventions

Coronary function testing DIAGNOSTIC_TEST

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

Also known as: CFT

Percutaneous coronary intervention + coronary function testing

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention performed according to local practice standards and guidelines

Also known as: PCI

Percutaneous coronary intervention; Percutaneous coronary intervention + coronary function testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Vasospasm; Angina, Stable

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04