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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01943903
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Providing written informed consent
* Subjects with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD who:
* In Cohort 1A \& 2A only are scheduled to undergo initial clinically-indicated non-invasive coronary evaluation, and have not undergone non-invasive coronary evaluation, including exercise tolerance testing, stress echocardiography, SPECT or MRI, or cCTA, within the past 90 days OR ICA at any time; or
* In Cohort 1B \& 2B only have been referred to invasive coronary angiography (ICA) and have not undergone ICA within the past 90 days
* Ability to undergo cCTA
Exclusion Criteria:
* Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out a myocardial infarction.
* Prior, clinically documented myocardial infarction
* PCI prior to first test
* CABG prior to first test
* Contraindications for cCTA such as:
* Presence of pacemaker or internal defibrillator leads
* Atrial Fibrillation
* Known anaphylactic allergy to iodinated contrast
* Pregnancy or unknown pregnancy status in women of childbearing potential
* Body mass index \>35 kg/m2
* Contraindication to acute beta blockade
* Contraindication to acute sublingual nitrate administration
* Prosthetic heart valve
* Contraindications to FFRCT
* Complex Congenital Heart disease other than anomalous coronary origins alone
* Ventricular septal defect with known Qp/Qs\>1.4
* Requiring an emergent procedure within 48 hours of presentation
* Evidence of active clinical instability, including cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, or NYHA Grade III or IV congestive heart failure or acute pulmonary edema
* Any active, serious, life-threatening disease with a life expectancy of less than 2 years
* Inability to comply with study follow-up requirements
* Current participation in any other clinical trial involving an investigational device or dictating care pathways at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01943903
Study Brief:
Protocol Section:
NCT01943903