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:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT06854458
Eligibility Criteria:
Inclusion Criteria:
1. male or female at age 35-85 years,
2. presence of either of the following sign/symptom that led to a referral to stress cardiac magnetic resonance imaging:
1. chest pain or anginal equivalent, or
2. abnormal electrocardiogram with a suspicion of coronary artery disease
3. Intermediate or high risk of significant coronary disease based on at least 1 of the following conditions:
a) patient age \> 45 for male, 50 for female b) Diabetes, hypertension, or hypercholesterolemia: by either history or medical treatment c) family history of premature coronary disease: first degree relative at age \<= 55 male and \<=65 female d) history of smoking of \> 10 packed-years e) post-menopausal state \>5 years f) any chronic inflammatory conditions d) Body mass index \> 30 e) Any medical documentation of coronary or peripheral artery disease
Exclusion Criteria:
1. Acute myocardial infarction within the past 30 days prior to cardiac magnetic resonance imaging
2. Confirmed diagnosis of any significant non-coronary cardiac conditions below:
1. any severe-grade valvular heart disease,
2. left ventricular ejection fraction \<40% from any known non-coronary causes,
3. infiltrative cardiomyopathy,
4. hypertrophic cardiomyopathy,
5. pericardial disease with significant constriction, or
3. active pregnancy,
4. any competing conditions leading to an expected survival of \< 2 years
5. contraindication to vasodilator (regadenoson or adenosine)
6. metallic device or object that poses an magnetic resonance imaging safety hazard
7. metallic device with a high likelihood of non-diagnostic cardiac magnetic resonance images
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT06854458
Study Brief:
Protocol Section:
NCT06854458