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:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT02507050
Eligibility Criteria:
Inclusion Criteria:
1. Symptoms of Angina Pectoris
2. Angiographic evidence of epicardial coronary artery stenosis referred for PCI
3. Flow limiting lesion (Fractional Flow Reserve ≤0.80) in one of following locations (as defined in SYNTAX trial89):
1. Proximal or mid left anterior descending artery (LAD)
2. Proximal or mid dominant right coronary artery (RCA)
3. Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel
4. Existing beta blocker prescription
5. Echocardiogram performed within preceding 12 months
6. Patient consent
Exclusion Criteria:
1. Previous myocardial infarction (MI) in target vessel myocardial territory or any MI in preceding 12 months (defined by patient history, ECG changes and evidence of regional wall motion abnormalities on echocardiography)
2. FFR\>0.80 in target vessel at time of procedure
3. Requirement for Multi-vessel intervention in a single procedure
4. Any chronic total occlusion (100% epicardial occlusion) on angiography
5. Distal coronary artery stenosis or that affecting non-dominant RCA
6. Heart Rate \<60 bpm at inclusion (assessed by 12 lead ECG after minimum 10 minutes rest period)
7. Any rhythm other than sinus rhythm
8. Sick sinus syndrome or high grade atrio-ventricular block
9. Permanent Pacemaker in situ
10. Congenital QT Syndrome
11. Intolerance or allergy to beta-blockers
12. Intolerance to Ivabradine
13. Additional (other than angina pectoris) indication for beta-blocker treatment e.g. ventricular tachycardia
14. Concurrent required use of rate-limiting drugs other than beta-blockers
15. The necessity of combination therapy with Ivabradine and bisoprolol to achieve heart rate control
16. Contraindication to Magnetic Resonance Imaging or IV adenosine
17. Severe impairment of renal function (eGFR\<30ml/min)
18. Severe Liver Disease (Any worse than Grade A by Child-Pugh Classification)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02507050
Study Brief:
Protocol Section:
NCT02507050