CAD, Prospective MemoryNCT05645770
Prospective Memory and Cardiac Activity in Coronary Artery Disease
An observational study of CAD, Prospective Memory, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Previous studies demonstrated an association between cognitive deficit and coronary artery disease (CAD; Abete et al., 2014; Deckers et al., 2017) even after controlling for the effects of age and socioeconomic status (Singh-Manoux et al., 2003). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- CAD, Prospective Memory
- What is being tested?
- ECG, computerized task
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2022to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The CAD group will be recruited from National Taiwan University Hospital Yunlin Branch. Written informed consent will be obtained before entering the study. Healthy controls will be recruited from neighboring communities, families of the patients or volunteers in the hospital. Matching procedure will consider age, education, and gender.
Who may be able to join
- (1) coronary artery disease noted by coronary angiogram or vascular computer tomography; (2) a history of percutaneous coronary intervention or coronary artery bypass surgery; (3) a history of myocardial infarction or unstable angina; (4) positive exercise electrocardiogram for myocardial ischemia; (5) positive stress radionuclide perfusion scan for myocardial ischemia or infarction; or (6) positive stress cardiac echography for myocardial ischemia.
Who cannot join
- stroke history, diagnosis of major psychiatric or neurological disorders (such as dementia, major depression, and traumatic brain injury), severe hearing or visual impairment, and movement disturbances.
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies demonstrated an association between cognitive deficit and coronary artery disease (CAD; Abete et al., 2014; Deckers et al., 2017) even after controlling for the effects of age and socioeconomic status (Singh-Manoux et al., 2003). A selective, non-amnestic cognitive impairment profile has also been observed in this patient group (Roberts et al., 2010), with executive function as the most vulnerable cognitive domain (Rostamian et al., 2015).
Prospective memory and CAD Prospective memory (PM) is another facet of executive function that concerns the realization of an intended action (Kvavilashvili, 1998). In addition to the support from memory system, PM strongly relies on attentional and executive control (Kliegel et al., 2011). For example, the two-stage cue-focused view of PM retrieval (McDaniel et al., 2004) posited the importance of "noticing" an action cue before the associated memory search can be initiated. PM is a clinically relevant psychological construct as the failure has been related to quality of life (Doyle et al., 2012), activities of daily living (Woods et al., 2008) and medication adherence (Zogg et al., 2012).
Read more
However, little is known about PM function in CAD. Only Habota et al. (2015) reported significant PM deficit in a small group of chronic heart failure patients (N = 19) as compared to healthy controls (N = 24). Therefore, the first aim of the present study is to examine PM performance in people with CAD as compared to their healthy controls.
Prospective memory and cardiac function The association between the brain and the heart has long been recognized (Samuels, 2007). However, the mechanism of cognitive impairment in CAD has not been clearly understood. Researchers proposed several contributing pathological routes including increased platelet activity, thrombo-embolic mechanisms or cardiac output reduction (Abete et al., 2014). The neurovisceral integration model (Smith et al., 2017) proposed a hierarchy of vagal control from intra-cardiac and cardiovascular reactions to representation of multimodal prior expectations that involve the cerebral executive control network. Accumulating evidence supported this notion by demonstrating the link between autonomic nervous system (ANS) and behavioral performance, such as the association between heart rate variability (HRV) and cognitive functions (Forte et al., 2019) and its moderating effect of resting pre-ejection time (PEP; Giuliano et al., 2017).
Few studies investigated the relationship between autonomic responses and PM. Kliegel et al. (2007) and Rothen et al. (2014) verified that there was an association between increased skin conductance responses (SCRs) and the noticing of PM cues in young adults. More recently, Umeda et al. (2016) found that PM performance was associated with an increase in heart rate upon target presentation and with better interoceptive accuracy in college students. They hypothesized that PM was regulated by cardiac afferent signals that facilitate saliency detection and intention retrieval, which was also mediated by interoceptive accuracy. These preliminary findings suggest close relationship between PM and autonomic functions and provide another aspect of the evidence on the brain-heart connection.
However, the methodology adopted in these studies suffered from crude, indirect measures of ANS activity. It is also unclear if the autonomic nervous function compromised by CAD (Montano et al., 2009) would play a role in PM deficit. Hence, the second aim of the present study is to investigate the relationship between PM and cardiac function as measured by HF-HRV (the parasympathetic component) and PEP (the sympathetic component).
- Conditions
- CAD, Prospective Memory
- Being tested
- ECG, computerized task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG, computerized taskCombination product
ECG for cardiac waves computerized task for prospective memory
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | Not described Receives: Combination Product: ECG, computerized task | |
| control | Not described Receives: Combination Product: ECG, computerized task |
What is being measured
The primary outcome is the main question the study is designed to answer.
PM function in CAD and the relationship of PM performance with parasympathetic and sympathetic measures of cardiac function.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start9 Dec 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD, Prospective MemoryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Chung Cheng University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645770
- Sponsor's protocol ID
- 202107146RINB
- Status last verified
- Sep 2022
- First submitted
- 1 Dec 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Memory and Cardiac Activity in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05645770
- Acronym / sponsor ID
- 202107146RINB
- Conditions
- CAD, Prospective Memory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Chung Cheng University
- Study start
- 9 Dec 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies demonstrated an association between cognitive deficit and coronary artery disease (CAD; Abete et al., 2014; Deckers et al., 2017) even after controlling for the effects of age and socioeconomic status (Singh-Manoux et al., 2003). A selective, non-amnestic cognitive impairment profile has also been observed in this patient group (Roberts et al., 2010), with executive function as the most vulnerable cognitive domain (Rostamian et al., 2015).
Prospective memory and CAD Prospective memory (PM) is another facet of executive function that concerns the realization of an intended action (Kvavilashvili, 1998). In addition to the support from memory system, PM strongly relies on attentional and executive control (Kliegel et al., 2011). For example, the two-stage cue-focused view of PM retrieval (McDaniel et al., 2004) posited the importance of "noticing" an action cue before the associated memory search can be initiated. PM is a clinically relevant psychological construct as the failure has been related to quality of life (Doyle et al., 2012), activities of daily living (Woods et al., 2008) and medication adherence (Zogg et al., 2012).
However, little is known about PM function in CAD. Only Habota et al. (2015) reported significant PM deficit in a small group of chronic heart failure patients (N = 19) as compared to healthy controls (N = 24). Therefore, the first aim of the present study is to examine PM performance in people with CAD as compared to their healthy controls.
Prospective memory and cardiac function The association between the brain and the heart has long been recognized (Samuels, 2007). However, the mechanism of cognitive impairment in CAD has not been clearly understood. Researchers proposed several contributing pathological routes including increased platelet activity, thrombo-embolic mechanisms or cardiac output reduction (Abete et al., 2014). The neurovisceral integration model (Smith et al., 2017) proposed a hierarchy of vagal control from intra-cardiac and cardiovascular reactions to representation of multimodal prior expectations that involve the cerebral executive control network. Accumulating evidence supported this notion by demonstrating the link between autonomic nervous system (ANS) and behavioral performance, such as the association between heart rate variability (HRV) and cognitive functions (Forte et al., 2019) and its moderating effect of resting pre-ejection time (PEP; Giuliano et al., 2017).
Few studies investigated the relationship between autonomic responses and PM. Kliegel et al. (2007) and Rothen et al. (2014) verified that there was an association between increased skin conductance responses (SCRs) and the noticing of PM cues in young adults. More recently, Umeda et al. (2016) found that PM performance was associated with an increase in heart rate upon target presentation and with better interoceptive accuracy in college students. They hypothesized that PM was regulated by cardiac afferent signals that facilitate saliency detection and intention retrieval, which was also mediated by interoceptive accuracy. These preliminary findings suggest close relationship between PM and autonomic functions and provide another aspect of the evidence on the brain-heart connection.
However, the methodology adopted in these studies suffered from crude, indirect measures of ANS activity. It is also unclear if the autonomic nervous function compromised by CAD (Montano et al., 2009) would play a role in PM deficit. Hence, the second aim of the present study is to investigate the relationship between PM and cardiac function as measured by HF-HRV (the parasympathetic component) and PEP (the sympathetic component).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | Combination Product: ECG, computerized task |
| control | – | Combination Product: ECG, computerized task |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The CAD group will be recruited from National Taiwan University Hospital Yunlin Branch. Written informed consent will be obtained before entering the study. Healthy controls will be recruited from neighboring communities, families of the patients or volunteers in the hospital. Matching procedure will consider age, education, and gender.
Key inclusion criteria (1 listed)
- (1) coronary artery disease noted by coronary angiogram or vascular computer tomography; (2) a history of percutaneous coronary intervention or coronary artery bypass surgery; (3) a history of myocardial infarction or unstable angina; (4) positive exercise electrocardiogram for myocardial ischemia; (5) positive stress radionuclide perfusion scan for myocardial ischemia or infarction; or (6) positive stress cardiac echography for myocardial ischemia.
Key exclusion criteria (1 listed)
- stroke history, diagnosis of major psychiatric or neurological disorders (such as dementia, major depression, and traumatic brain injury), severe hearing or visual impairment, and movement disturbances.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG, computerized taskECG for cardiac waves computerized task for prospective memory | Combination product | control, coronary artery disease |
Primary outcome
PM function in CAD and the relationship of PM performance with parasympathetic and sympathetic measures of cardiac function.
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CAD, Prospective Memory, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PM function in CAD and the relationship of PM performance with parasympathetic and sympathetic measures of cardiac function. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.