Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery
NCT04191642, Completed, General Hospital of Ningxia Medical University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery | ClinicalTrials.gov |
| NCT number | NCT04191642 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 75 participants, actual | ClinicalTrials.gov |
| Lead sponsor | General Hospital of Ningxia Medical University | ClinicalTrials.gov |
| Conditions | Inflammasomes, Cognitive Dysfunction, Pyrin Domain-Containing 3 Protein, Postoperative Complications | ClinicalTrials.gov |
| First posted | 2019-12-10 | ClinicalTrials.gov |
| Last updated | 2021-09-01 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The correlation between peripheral blood NLRP3 inflammasome level and incidence of postoperative cognitive dysfunction | The day before surgery, 7 days after surgery | Peripheral venous blood was sampled to measure NLRP3 inflammasome expression. POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD. The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more. Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test. Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score. | ClinicalTrials.gov |
| Secondary | The correlation between peripheral blood IL-1B levels and incidence of postoperative cognitive dysfunction | At the end of the surgery, 7 days after surgery | Peripheral venous blood was sampled to measure IL-1B expression. POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD. The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more. Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test. Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score. | ClinicalTrials.gov |
| Secondary | The correlation between peripheral blood IL-18 levels and incidence of postoperative | At the end of the surgery, 7 days after surgery | Peripheral venous blood was sampled to measure IL-18 expression. POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD. The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more. Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test. Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 10
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
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 |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)