Older People's Neurocognitive Recovery After Cardiac Surgery
NCT06469515, Recruiting, Karolinska Institutet
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Older People's Neurocognitive Recovery After Cardiac Surgery | ClinicalTrials.gov |
| NCT number | NCT06469515 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 220 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Karolinska Institutet | ClinicalTrials.gov |
| Conditions | Postoperative Cognitive Dysfunction, Postoperative Recovery, Cardiac Surgery | ClinicalTrials.gov |
| Interventions | Elective or urgent cardiac surgery | ClinicalTrials.gov |
| First posted | 2024-06-21 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Postoperative cognitive complaints | Before surgery and weekly up to three months after surgery | The Swedish Quality of Recovery cognitive version (SwQoR-Cog) is a self-assessment questionnaire that measures postoperative symptoms. The form consists of 14 statements regarding symptoms and discomforts, of which 11 address cognitive symptoms and 3 are related to pain and nausea. Symptoms and discomforts are rated on an 11-point scale (0=not at all to 10=all the time). | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 1 | Before surgery and 1, 3, and 6 months after surgery | Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after \~7 min. | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 2 | Before surgery and 1, 3, and 6 months after surgery | Trail Making Test (TMT- A \& B) consists of 25 circles with letters or numbers on the screen. | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 3 | Before surgery and 1, 3, and 6 months after surgery | Stroop Colour-Word Test (SCW). 24 words spelling out the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word. | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 4 | Before surgery and 1, 3, and 6 months after surgery | Symbol Digits Processing Test (SDPT). The test consists of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom. | ClinicalTrials.gov |
| Secondary | Postoperative delirium | Twice daily up to postoperative day 7 | The Nursing Delirium Scale (Nu-DESC) is an assessment scale where five symptoms are identified and evaluated. A total score of ≥ 2 points indicates the presence of delirium. | ClinicalTrials.gov |
| Secondary | Perceived self-efficacy | Before surgery and 1, 3, and 6 months after surgery | The Swedish General Self-Efficacy Scale (S-GSE) is an instrument that measures perceived self-efficacy in problem-solving and goal achievement. The tool consists of 10 statements that are answered on a 4-point scale, ranging from 1 (not at all true) to 4 (exactly true). This scale is designed to assess an individual's belief in their ability to cope with a variety of difficult demands in life. | ClinicalTrials.gov |
| Secondary | Depressive symtoms | Before surgery and 1, 3, and 6 months after surgery | The Patient Health Questionnaire (PHQ-9) is a questionnaire that measures depressive symptoms. The form consists of 9 statements that are answered on a 4-point scale (0=not at all to 3=nearly every day). A total score of ≥ 10 indicates depressive symptoms. | ClinicalTrials.gov |
| Secondary | Functional activity | Before surgery and 1, 3, and 6 months after surgery | The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a tool that measures the level of functioning. The instrument consists of 12 questions that address difficulties related to health conditions, which are rated on a 5-point scale (1=no difficulty to 5=extreme difficulty/cannot do). A change of ≥5% compared to the baseline measurement indicates a clinically significant difference in the level of functioning. | ClinicalTrials.gov |
| Secondary | Frailty | Before surgery and at 6 months after surgery | The Clinical Frailty Scale (CFS) is an assessment scale of frailty consisting of nine levels (1=very fit to 9=terminally ill). The assessment is conducted by trained healthcare professionals by having the patient (or a relative) answer questions about their level of capacity two weeks prior. | ClinicalTrials.gov |
| Secondary | Fatigue | Before surgery and at 6 months after surgery | The Fatigue Scale for Motor and Cognitive Functions (FSMC) is a questionnaire that measures extreme forms of fatigue. The form consists of 20 statements concerning extreme fatigue and how it affects the participant's daily life and is answered on a 5-point scale (1= not true at all to 5= completely true). The FSMC measures both cognitive and physical fatigue. A total score of ≥ 43 indicates mild fatigue, ≥ 53 indicates moderate fatigue, and ≥ 63 indicates severe fatigue. | ClinicalTrials.gov |
| Secondary | Health-related quality of life as assessed by RAND-36 | Before surgery and at 6 months after surgery | RAND-36 is a questionnaire that measures health-related quality of life. The survey consists of 36 questions that assess 8 different domains of health: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, emotional well-being, vitality, pain, and general health. Two different composite scores can be calculated for physical and mental health status, where a score of 50 or above indicates poor physical/mental health status. | ClinicalTrials.gov |
| Secondary | Close relatives' assessment of cognition | Before surgery and 1, 3, and 6 months after surgery | The Cognitive Failures Questionnaire for Others (f-CFQ) will be used to measure relatives' assessment of the patient's cognition. The instrument consists of 8 questions that assess the frequency of cognitive problems in daily life related to memory, attention, motor skills, and perception. The questions are answered on a 4-point scale ranging from (0=never to 4=very often). | ClinicalTrials.gov |
| Secondary | Caregiver burden | Before surgery and 1, 3 and 6 months after surgery | The Short Form Zarit Burden Interview (ZBI-12) will be used to measure caregiver burden. ZBI-12 consists of 12 questions that are answered on a 5-point scale (0=never to 4=almost always). | ClinicalTrials.gov |
| Secondary | Experiences of cognitive recovery | At 6 months after surgery | Qualitative semi-structured interviews | ClinicalTrials.gov |
| Secondary | Close relatives experience | At 6 months after surgery | Qualitative semi-structured interviews | ClinicalTrials.gov |
| Secondary | Unplanned healthcare visits | At 6 months after surgery | Study-specific questionnaire where participants will register any unplanned contacts or visits with healthcare services. | ClinicalTrials.gov |
| Other | Demographic and perioperative data | At baseline and perioperatively | Will be collected from the medical record. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40545303 | DERIVED | PubMed |
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 4
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 | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | 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)