Trial · NCT03252093
Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG
NCT03252093, Phase 2, Terminated, University of Arizona
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG. Trials, record NCT03252093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03252093
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG
- NCT number
- NCT03252093
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Arizona
- Conditions
- Coronary Artery Bypass Surgery, Cognitive Impairment
- Interventions
- Angiotensin-(1-7), Placebo for Angiotensin-(1-7)
- First posted
- 2017-08-17
- Last updated
- 2025-06-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Demonstrate 21 days daily administration of Ang-(1-7) in participants undergoing 1st time CABG surgery is safe and efficacious as assessed by the number of related AEs grade 3 or > and change in composite neuropsychological score up to Day 90. | Up to Day 90 | Adverse events (AEs), including serious adverse events (SAEs) will be monitored from the time of enrollment through Day 90. The number of AEs, withdrawals due to AE, and withdrawals for other reasons will be tabulated. Additional assessments include: serum blood levels of the Ang-(1-7) at Day 1, Day 3, Day 5 or Discharge and Day 21. Lastly blood pressuring monitoring pre and post treatment will occur Day 1 to discharge. Change in performance on composite scores of memory, executive functioning, language and processing speed in the treatment arm compared to placebo arm and non-surgical controls measured at 3 time points will assess the effectiveness of Ang-(1-7) in reducing postoperative cognitive impairment in CABG patients. |
| Secondary | Demonstrated change in the neuropsychological component scores assessed at baseline, Day 21 and Day 90 in the treatment and placebo arms. | Up to Day 90 | The component scores to be analyzed will include Rey Auditory Verbal Learning Test (RAVLT) and Confusion Assessment Method (CAM), assessment of general intellectual functioning (North American Adult Reading Test), prospective memory (MIST; Memory Intentions Test) , Visual Paired Associates, Object-Spatial Locations, three areas of executive functions including updating (Keep Track), shifting (Letter-Number), and inhibition (Stroop Color-Word), and psychomotor speed (Deary Simple and Complex Reaction Times, Trials A and B). |
| Secondary | Evidence of change in fractional anisotropy from diffusion tensor imaging on Brain MRI at baseline versus post operative Day 21 will be assessed in the treatment and placebo arms as a measure of efficacy. | Up to Day 21 | CABG surgery will result in observable changes in gray matter volumes and integrity of white matter as measured by structural and diffusion MR imaging in all participants. Similar voxel-based multivariate regression analyses will be used for other MRI measures including gray and white matter volumes, axial and radial diffusion, and ASL perfusion. Comparisons between CABG patients and controls will use the general linear model in SPM8 with group (CABG, controls) as a categorical factor and age as a mean-centered control variable. For structural MRI, ICV will also be included as a covariate. |
| Secondary | Demonstrated change in PBR28 VT/fP, a quantitative measure of TSPO receptor density, in a composite cerebral region-of-interest (ROI) derived from brain PET imaging in the treatment and placebo arms. | Up to Day 21 | PBR28 VT/fP will be measured in a composite cerebral region-of-interest (ROI), including automatic anatomically labeled, bilateral medial and lateral temporal, parietal, precuneus, prefrontal ROIs (Reiman, 2009) in the treatment and placebo arms. |
| Secondary | Demonstrated associations between neuropsychogical test results, MRI findings and PBR28 binding in all participants. | Up to Day 90 | Neuropsychological testing outcomes and MRI findings will analyzed to evaluate associations between these outcomes and PBR28 binding. In addition, systemic inflammatory markers will be measured, including GM-CSF, IFNγ, IL-1 β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, and TNFα. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL131014 | Evaluation of the Safety and Efficacy of Angiotensin 1-7 to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery | SWEITZER, NANCY K; ARAI, ANDREW E; HAY, MEREDITH; RYAN, LEE | UNIVERSITY OF ARIZONA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03252093
GET https://conductscience.org/api/trials/v1/NCT03252093/registered