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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05618132
Eligibility Criteria:
Inclusion Criteria:
* Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)
* Non-obstructive coronary artery disease is defined as the absence of coronary artery stenosis ≥ 50%, or if ≥ 50% with non-ischemic resting (RFR \> 0.89) and hyperemic indices (FFR \> 0.80).
* ACH provoked epicardial and/or microvascular spasm
* Left ventricular ejection fraction (LVEF) \> 50%
* Renal function with eGFR ≥ 40 ml/min
Exclusion Criteria:
* Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)
* Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease
* LVEF \< 50%
* Long QT syndrome (LQTS) - genetic or acquired
* Ventricular paced rhythm
* Renal failure with eGFR \< 40 ml/min
* Thyroid stimulating hormone (TSH) \< lower limit of normal (LLN). A subject taking thyroid replacement therapy may be enrolled with TSH level below LLN if, in the opinion of the investigator, the subject is in a clinically euthyroid state.
* Known hypersensitivity or contra-indication for either acetylcholine, verapamil, nicorandil or nitroglycerine.
* Pregnant female subjects. Female subjects of child-bearing potential should be on adequate contraceptive measures or are to be screened with a urine pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05618132
Study Brief:
Protocol Section:
NCT05618132