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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT03797118
Eligibility Criteria:
Inclusion Criteria:
1. Patients providing written informed consent
2. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
3. Has undergone \>640 multidetector CCTA within 60 days prior to ICA
4. No cardiac interventional therapy between the CCTA and ICA
Exclusion Criteria:
1. Prior coronary artery bypass graft (CABG) surgery
2. Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
3. Contraindication to adenosine, including 2nd or 3rd-degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, severe COPD or bronchodilator-dependent COPD
4. Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
5. Recent prior myocardial infarction within 40 days of ICA
6. Known complex congenital heart disease
7. Prior pacemaker or internal defibrillator lead implantation
8. Prosthetic heart valve
9. Significant arrhythmia or tachycardia
10. Impaired chronic renal function (serum creatinine \>1.5 mg/dl
11. Patients with known anaphylactic allergy to iodinated contrast
12. Pregnancy or unknown pregnancy status
13. Body mass index \>35
14. Patient requires an emergent procedure
15. Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
16. Any active, serious, life-threatening disease with a life expectancy of less than 2 months
17. Inability to comply with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03797118
Study Brief:
Protocol Section:
NCT03797118