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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT02538861
Eligibility Criteria:
Inclusion Criteria:
1. The patient is \> 35 years of age.
2. The patient had an episode of chest pain at rest or during exercise within the previous 24 hours.
3. The patient is classified as "Level 3" in the 5-Level Miami Baptist Chest Pain Protocol (Cury R et al. AJR, 2012; 200: 57-65) (44) or The patient is classified as "Level 4" in the 5-Level Miami Baptist Chest Pain Protocol, and has either a 40-70% stenosis by coronary CT angiography, an Agatston Calcium Score \>400, or non-evaluable segments in coronary CT angiography due to calcifications, motion artifacts, or other technical reasons. (Level 4 patients who have already been scan for CTA; will not have to repeat the CTA. Eligible Level 4 patients will only go for CT Myocardial Perfusion scan.
4. Women of childbearing potential have a negative pregnancy urine or serum test.
5. The patient understands the study requirements and procedures and provides written informed consent using a form that has been approved by the Institutional Review Board (IRB) before any study specific test or procedures are performed.
6. The patient is willing to comply with the specified follow-up telephone call.
Exclusion Criteria:
1. The patient is classified as "Level 1", "Level 2", or "Level 5" in the 5-Level Miami Baptist Chest Pain Protocol (Cury R et al. AJR, 2012; 200: 57-65). This includes patients with STEMI (Level-1), NSTEMI or Unstable Angina (Level-2) and non-cardiac chest pain patients (Level-5)
2. Known allergy to iodinated contrast agent or creatinine \>1.5mmol/L.
3. Atrial Fibrillation, Flutter or irregular heart rhythm.
4. Known history of severe asthma.
5. Body Mass Index (BMI) \>45.
6. Patients in unstable conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT02538861
Study Brief:
Protocol Section:
NCT02538861