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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT01905566
Eligibility Criteria:
Inclusion Criteria:
* Men or Women at least 18 years of age inclusive
* Patients with acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC, NSTEMI or STEMI)
* FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
* The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
* Patients treated with carotid endarterectomy or stent placement
* Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
* Untreated hyperthyroidism, or hypothyroidism
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
* Evidence of congestive heart failure, or left ventricular ejection fraction \< 40%.
* Significant renal disease manifested by serum creatinine \> 2.0mg/dL, or creatinine clearance of \< 40 ml/min (by Cockcroft-Gault method).
* Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
* History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
* Unwillingness or inability to comply with the procedures described in this protocol.
* Patient's pregnant or breast-feeding or child-bearing potential.
* Type I Diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01905566
Study Brief:
Protocol Section:
NCT01905566