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NCT Number: NCT07829380

The Cardiovascular-Cognitive Health Initiative

This study aims to understand how memory and thinking abilities (cognition) are affected in patients with heart conditions, and to find out if early detection and interventions can improve health outcomes.

Recruiting

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandra Hospital, Singapore

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About this study

Cardiovascular disease (CVD) and cognitive impairment frequently coexist in aging populations and accelerate each other's deterioration through shared vascular and neurobiological pathways.

Primary objectives:

i. To determine the prevalence and profile of cognitive impairment in patients with cardiovascular disease

ii. For the RCT, to compare the proportion of patients who demonstrate improvement in cognitive test scores by 24 weeks between intervention and usual care arms.

Secondary objectives:

i. To evaluate changes in neuropsychological domains (e.g. memory, processing speed), mental health, frailty, and quality of life over time.

ii. To study the association between cognitive status and cardiovascular treatment plan categories.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Main Study:

  • Age ≥ 21 years.
  • Able and willing (or via legally acceptable representative, LAR, where appropriate) to provide informed consent.

RCT Sub-Study (Mild cognitive impairment (MCI) arm):

  • Meets main study criteria.
  • Mild cognitive impairment defined by: (i) Montreal cognitive assessment (MoCA) <26 but ≥21; and/or (ii) impairment in at least one domain on standardized neuropsychological testing and/or (iii) MMSE <28 but ≥24.

Exclusion criteria

  • Neurodegenerative disorders or major psychiatric illnesses that substantially impair cognition.
  • Terminal illness or advanced major organ disease limiting participation with expected survival of less than 1 year.
  • Severe depression, anxiety, or stress where participation may be inappropriate.
  • Any condition which, in the investigator's opinion, would compromise safety or study integrity.

Note: Pregnant and breast-feeding women may not take part in this study.

Treatment and study plan

Structured cognitive and cardiovascular interventions

Other

The intervention arm (RCT R1 cohort) will receive a 24-week multi-component program combining cardiac rehabilitation instruction, cognitive stimulation via a hybrid hospital and home-based telehealth platform.

Primary outcomes

  1. Primary RCT Outcome

    Time frame: 24 weeks

    Proportion of participants demonstrating clinically meaningful improvement in cognitive function at 24 weeks, defined as a pre-specified increase in standardized cognitive test scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela S. Koh, MBBS

CONTACT

[email protected]

+6567048961

Mee Yin Wong, BSc

CONTACT

[email protected]

+6567042302

Sponsors and collaborators

Lead sponsor

National Heart Centre Singapore

Other

Registry information

Acronym: COGENT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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