Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07472634
Eligibility Criteria:
Inclusion Criteria
1. Age 18-90 years.
2. Signed informed consent to participate in the study.
3. Positive medical history suggestive of chronic coronary syndrome (CCS).
4. Diagnostic CCTA performed no more than 122 days prior to the planned ICA, of sufficient quality to assess the entire coronary tree (both arteries reconstructable in a single series), demonstrating at least one ≥50% stenosis in an epicardial coronary artery \>2.0 mm in diameter, not previously revascularized.
5. Planned ICA with the intention to perform FFR measurement no later than 122 days after the CCTA.
6. Stable treatment for CCS without the need for dose adjustments for at least 30 days prior to study inclusion.
Exclusion Criteria
1. Presence of myocardial bridging on CCTA causing \>50% systolic narrowing of an epicardial coronary artery, per Investigator's assessment.
2. Complications occurring during CCTA that reduce the safety or feasibility of CTP (per treating physician decision).
3. Stenosis of the left main coronary artery \>40%.
4. Myocardial infarction occurring between CCTA and ICA, documented by elevated cardiac biomarkers (troponin, myoglobin) or new wall motion abnormalities or new coronary occlusion.
5. History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the last 90 days. Not applicable to patients undergoing functional testing with regadenoson.
6. Atrioventricular block (type II-III), prolonged QT interval, or sick sinus syndrome.
7. Renal insufficiency (creatinine ≥1.6 and/or glomerular filtration rate \<30 ml/m²) or renal failure requiring dialysis.
8. Persistent atrial fibrillation.
9. BMI \>40.
10. Implanted pacemaker or internal cardioverter-defibrillator.
11. Pregnancy or inability to exclude pregnancy.
12. Hemodynamic instability per treating physician, including but not limited to: cardiogenic shock, hypotension (systolic blood pressure \<90 mmHg), treatment-resistant hypertension (systolic blood pressure \>180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medication.
13. Significant allergies or adverse reactions (per Investigator) to iodinated contrast agents, adenosine, regadenoson, or aminophylline. Contraindications include: anaphylactic shock, angioedema.
14. Significant valvular heart disease-at least moderate regurgitation or stenosis.
15. Structural heart disease, including post-corrective procedures.
16. Malignant coronary artery anomaly.
17. History of myocardial infarction.
18. Prior coronary artery bypass grafting (CABG).
19. Prior PCI if the target vessel for evaluation has previously undergone PCI.
20. Chronic total occlusion (CTO) of a coronary artery.
21. Left ventricular ejection fraction (LVEF) ≤35%.
22. Presence of conditions that, in the Investigator's opinion, may significantly change the patient's health status within 122 days.
23. Other relevant comorbidities, infections, addictions, or psychological or social factors that, in the Investigator's opinion, may impair participation in the study or significantly affect patient safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07472634
Study Brief:
Protocol Section:
NCT07472634