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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01353612
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients over the age of 18 years.
* Patients scheduled for clinically indicated coronary angiography and possible ad hoc percutaneous coronary intervention (PCI) will be evaluated before their scheduled procedure.
* Written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific procedures.
* Patients considered to be stable at enrollment (at the discretion of the investigator) are eligible provided they meet all other entry criteria.
* Angiogram meeting qualifying criteria
Exclusion Criteria:
* Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who refuse to undergo a urine or serum pregnancy test immediately prior to baseline and repeat imaging evaluations The urine or serum pregnancy test must be negative prior to imaging evaluations.
* Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 24 months.
* Patients who have symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class III or IV) at baseline.
* Patients with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study
* Any clinically significant medical condition or presence of any laboratory abnormality that is considered by the investigator to be clinically important and could interfere with the conduct of the study.
* The presence of severe liver disease as defined by the presence of cirrhosis, chronic active hepatitis, or chronic jaundice with hyperbilirubinemia,
* Patients with eGFR \< 45 ml/min prior to baseline imaging procedures, or with nephrotic syndrome
* Patients with a life expectancy less than 2 years.
* History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.
* Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01353612
Study Brief:
Protocol Section:
NCT01353612