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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT00246493
Eligibility Criteria:
* INCLUSION CRITERIA:
For all groups:
1. Age 30 years or older
2. Ability and willingness to participate in the protocol and undergo vascular studies and chest MDCT examinations
For the second group:
1\) Coronary artery calcium score of zero or less than 25th percentile of that expected based on age and gender.
For the third group:
1\) Coronary artery calcium score which is greater than the 50th percentile of that computed based on age and gender, or known coronary disease on the basis of:
i. prior documented myocardial infarction or
ii. typical ischemic symptoms and catheterization documented stenosis of greater than or equal to 70% in at least one major coronary artery
If male, diagnosis was made under 50 years of age
If female, diagnosis was made under 60 years of age.
EXCLUSION CRITERIA
1. Atrial fibrillation (due to limitations with gating on MDCT)
2. For the first 2 groups: History of procedures used for treatment of CVD (CABG, angioplasty, pacemaker or defibrillator implantation, any surgery on the heart or the arteries)
3. Active treatment for cancer
4. Serious medical condition which could hinder participation or make it unlikely that they will live for three years (for f/u)
5. Weight\>300 lb (maximum weight allowed on CT tables)
6. Inability to provide an informed consent
7. For females, current pregnancy because of the radiation associated with the helical CT and the unknown risks to a fetus. This is only temporary, and women wishing to participate may be enrolled six weeks after delivery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00246493
Study Brief:
Protocol Section:
NCT00246493