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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT05199428
Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness to give written informed consent
* Age 18 years or older at the time of informed consent
* Stable (non-emergent) typical or atypical symptoms suspicious for CAD (e.g., chest pain, chest tightness, chest burning, shoulder pain, palpitations, jaw pain, or non-chest pain symptoms such as dyspnea or worsening effort tolerance.
* Patients having undergone clinically-indicated invasive coronary angiography or coronary computed tomography angiography within one month before consent signature
Exclusion Criteria:
1. At Screening Visit 1:
1. Asymptomatic subjects
2. Previous coronary revascularization (e.g., coronary artery bypass graft surgery, stenting)
3. Subjects being evaluated for other cardiac diseases (e.g., valvular disease, cardiomyopathy)
4. Pregnant or breastfeeding women
2. At Study Visit 2 or Ocular Exclusion Criteria:
1. Medium or high opacity of the lens
2. Bleeding in vitreous
3. Pupillary dilation inadequate or contraindicated
4. Deficient visual fixation
5. Refractive error outside of the range -15 to +15
6. Inability to obtain satisfactory images with the MHRC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05199428
Study Brief:
Protocol Section:
NCT05199428