NCT05645770

Brief 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). 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 12, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

December 1, 2022

Last Update Submit

December 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • PM function in CAD and the relationship of PM performance with parasympathetic and sympathetic measures of cardiac function.

    2 hours

Study Arms (2)

coronary artery disease

Combination Product: ECG, computerized task

control

Combination Product: ECG, computerized task

Interventions

ECG, computerized taskCOMBINATION_PRODUCT

ECG for cardiac waves computerized task for prospective memory

controlcoronary artery disease

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • (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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Douliu, Taiwan

Location

MeSH Terms

Interventions

epicatechin gallate

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 12, 2022

Study Start

December 9, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 12, 2022

Record last verified: 2022-09

Locations