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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01000233
Eligibility Criteria:
Inclusion Criteria:
* Calcium in the aortic valve, characterized by Rosenhek score grade 2 or 3 in echocardiography and / or with not severe coronary calcification detected in other studies (angiography, CT).
Exclusion criteria:
* Severe aortic (Rosenhek 4)or coronary calcification .
* Positive pregnancy test (if pregnancy occurs during the study be deferred final evaluation at the end of gestation, if the patient wishes to continue in the study).
* Addiction to drugs or alcohol.
* Renal insufficiency (serum creatinine\> 2mg/dl).
* Liver disease or cirrhosis.
* Severe valve disease or requiring surgery during the study.
* Unstable ischemic heart disease (revascularization in the last 3 months).
* Atrial fibrillation in the initial evaluation (difficulty in measuring Ca). May be included later if sinus rhythm is achieved stable for at least three months.
* The need for any medication in relation to calcium metabolism (PTH, bisphosphonates, strontium ranelate, raloxifene, oral calcium, vitamin D, calcitonin, etc.).
* Participation in another trial in the three months prior to evaluation.
* Suspected difficulties to accomplish during the two years, for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01000233
Study Brief:
Protocol Section:
NCT01000233