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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00539604
Eligibility Criteria:
Inclusion Criteria:
1. Patients (men or women of any ethnic group) scheduled for a coronary angiography evaluation for a diagnostic work up.
2. Patients will be expected to undergo coronary angiography within 2 weeks after the MDCT study procedure. The coronary angiography must meet the minimum standard laid down in the protocol (see section 8.3.3).
3. Patients must have HDL and total cholesterol performed within the last year.
4. Patients must be willing and able to continue study participation following the reference test to ensure completion of all procedures and observations required by the study.
5. Fully informed and signed consent must be obtained from each patient.
\-
Exclusion Criteria:
1. Patients under 18 years of age.
2. Patients who have received any investigational drug within the 30 days prior to entering this study.
3. Pregnant or lactating women.
4. Patients who have any contraindication to MDCT examination with iodinate contrast media.
5. Patients with heart rate \>70 bpm despite of β-blocker treatment (see section 8.2.4.1).
6. Patients with no sinus rhythm.
7. Patients with NYHA III or IV class.
8. Patients who have previously undergone CABG or stenting.
9. Patients with a creatinine value \> 2 mg/dl.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00539604
Study Brief:
Protocol Section:
NCT00539604