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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT01052532
Eligibility Criteria:
Inclusion Criteria:
1. 21 years old or older.
2. Severe MR by echo or catheterization without evidence of ischemia requiring surgery documented by cardiac catheterization and/or maximal stress test with myocardial perfusion imaging.
Exclusion Criteria:
1. Significant obstructive coronary artery disease and/or myocardial ischemia on graded exercise test with myocardial perfusion.
2. Previous myocardial infarction.
3. Hypertrophic cardiomyopathy, congenital or pericardial disease.
4. Aortic valve disease (\> trace aortic regurgitation or mean gradient \> 10 mmHg)
5. Mitral stenosis (mean gradient \> 5 mmHg, valve area \< 1.5 cm2).
6. Renal failure with creatinine \> 2.5 mg/dl.
7. Renal artery stenosis.
8. Severe comorbidity such as liver disease, malignancy, collagen vascular disease, or chronic steroid requirement.
9. Pregnancy (negative pregnancy test and effective contraceptive methods are required prior to enrollment of females of childbearing potential (not post-menopausal or surgically sterilized).
Exclusion Criteria Related to MRI
1. Severe claustrophobia.
2. Presence of a pacemaker or non-removable hearing aid.
3. Presence of metal clips in the body.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01052532
Study Brief:
Protocol Section:
NCT01052532