Status:
TERMINATED
Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Suburban Hospital
Conditions:
Coronary Artery Bypass Surgery
Cognitive Impairment
Eligibility:
All Genders
60-80 years
Phase:
PHASE2
Brief Summary
Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with cognitive impairment. Mechanisms of cognitive impairment are complex but may include insufficient oxygenation an...
Detailed Description
Up to 104 participants (ages 60-80) undergoing elective CABG surgery at the Banner University Medical Center in Tucson, AZ or at Suburban Hospital/NIH Clinical Center in Bethesda, MD, will be enrolled...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03252093
Start Date
July 20 2017
End Date
November 15 2022
Last Update
June 4 2025
Active Locations (5)
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1
Banner- University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
University of Arizona Sarver Heart Center
Tucson, Arizona, United States, 85724
3
Suburban Hospital
Bethesda, Maryland, United States, 20814
4
National Institutes of Health
Bethesda, Maryland, United States, 20892