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 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07422818
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 90 years;
2. ICA performed within the previous 12 months from enrollment and characterized by: (a) absence of obstructive CAD (\<50% diameter reduction or FFR by \>0.80); (b) invasive assessment of epicardial/microvascular spasm by acetylcholine test;
3. Signed informed consent.
Exclusion Criteria:
1. Presentation as an acute coronary syndrome (i.e. unstable chest pain) or a typical history of variant angina (frequent angina pain at rest with ST-segment elevation at the ECG, caused by recurrent coronary spasm);
2. Previous coronary revascularization with surgical intervention;
3. Asthma or known intolerance or contraindications to dipyridamole;
4. Serious medical conditions, including renal failure (eGFR \<30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
5. Pregnancy;
6. Psychological conditions that might hamper patient co-operation;
7. Any condition that, in the judgment of the investigators, would make difficult for the patient to complete the study protocol;
8. Missed informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07422818
Study Brief:
Protocol Section:
NCT07422818