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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT01174550
Eligibility Criteria:
Inclusion Criteria:
* new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)
* no prior evaluation for this episode of symptoms
* planned non-invasive testing for diagnosis
* men age ≥55 years
* men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \>50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented \> 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than \<0.9, 4-Dyslipidemia
* women age ≥65 years
* women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \>50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented \> 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than \<0.9, 4-Dyslipidemia
* Serum creatinine ≤ 1.5 mg/dL within the past 90 days
* Negative urine/serum pregnancy test for female subjects of child-bearing potential
Exclusion Criteria:
* Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)
* Hemodynamically or clinically unstable condition systolic blood pressure (BP) \< 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
* Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel
* Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months
* Known significant congenital, valvular (\> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms
* Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate \< 65 beats per minute, c. Pregnancy
* Life expectancy \< 2 years
* Unable to provide written informed consent or participate in long-term follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01174550
Study Brief:
Protocol Section:
NCT01174550