Menu
Not yet recruiting NCT07449052

Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

No phase Interventional Coronary Artery Disease (CAD) Obstructive Coronary Artery Disease Coronary Microvascular Dysfunction (CMD) Vasospasm, Coronary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary function testing, Percutaneous coronary intervention.
Who it may be relevant to
Registry conditions: Coronary Artery Disease (CAD), Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD), Vasospasm, Coronary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Inclusive Invasive Physiological Assessment in Angina Syndromes - Obstructive Coronary Artery Disease

Overview

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

Interventions

  • Diagnostic test Coronary function testing
    Coronary function testing to test for coronary microvascular dysfunction and coronary vasospasm
  • Procedure Percutaneous coronary intervention
    Percutaneous coronary intervention performed according to local practice standards and guidelines

Primary outcome measures

  • Angina symptom burden [Time frame: From baseline to 6 months of follow-up (after procedure)]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07449052 · ILIAS OBSTRUCTIVE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗