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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT03057002
Eligibility Criteria:
Inclusion Criteria for Control Subjects:
* Subjects who are 18.
* Subjects who have the ability to understand and the willingness to sign a written informed consent.
* While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Inclusion Criteria for participants with Cardiomyopathy:
* Subjects who are 18.
* Subjects who have the ability to understand and the willingness to sign a written informed consent.
* While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion criteria:
* Subjects who are receiving any other investigational agents.
* Intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled chronic diseases such as hypertension, lung disease, liver disease, kidney disease, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects who are taking thyroid hormone replacements, have a history of alcohol abuse or illicit drug use.
* Subjects who have contraindication to contrast enhanced MRI examination.
Contraindications to MRI examinations include:
* Medically unstable
* Acute Heart failure
* Severe LVOT obstruction
* Unstable angina
* Child bearing
* Lactating
* Any contraindication per MRI Screening Form including
* Implants contraindicated at 3Tesla, pacemakers
* Implantable Cardioverter Defibrillator (ICD)
* Claustrophobia
* Since each subject is receiving a gadolinium based contrast agent intravenously:
* eGFR ≤ 30 mL/min/1.73m2
* Sickle cell disease
* Hemolytic anemia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03057002
Study Brief:
Protocol Section:
NCT03057002