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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03252093
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female first time cardiac surgical participants
* Elective on pump coronary artery bypass grafting (CABG)
* Age 60-80
* Signed, informed consent
* Geriatric Depression Scale score less than or = 14or Beck's Depression Inventory less than or = 20
* Score \> or = 25 on the Mini-Mental State Examination (MMSE)
Exclusion Criteria:
* Recent (within 60 days) Cerebrovascular disease with neurological change
* Malignancy or pre-malignant state within 5 years not including non-melanoma skin cancer
* History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (ULN) at screening).
* History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dL at screening).
* Significant Lung Disease (FEV1\< 1.5 L, pO2 \<70 on room air, pCO2 \>45)
* Presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder.
* Active substance abuse
* Less than Grade 7 education or inability to read and perform cognitive assessment.
* Significant neurological disorder affecting memory
* Uncontrolled atrial fibrillation prior to surgery
* Concurrent use of prescription medications specifically for memory enhancement including herbal or natural supplements
* General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization.
* Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization.
* Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy.
* Participants on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months
* Receipt of any investigational agent or device within 30 days of screening
* MRI contraindication not limited to abnormally high weight or height to fit in scanner (Bore 70cm); Presence of device/hardware incompatible with MR imaging
* Conditions causing severe anemia
* Participant is practicing Jehovah Witness
* Sexually active males not practicing a medically acceptable method of contraception, unless there is documented azoospermia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT03252093
Study Brief:
Protocol Section:
NCT03252093