The Cardiovascular-Cognitive Health Initiative

ConditionCognitive Impairment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-99

SponsorNational Heart Centre Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 21 years.

Able and willing (or via legally acceptable representative, LAR, where appropriate) to provide informed consent.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Structured cognitive and cardiovascular interventions
Other intervention
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.

Treatment groups

5,000 Participants

are divided into 3 treatment groups

Group A: Main (Observational) CohortNo intervention 0 interventions

Group B: Randomized Controlled Trial (RCT) R1 CohortOther 1 intervention

Group C: Randomized Controlled Trial (RCT) R2 CohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

Primary RCT Outcome

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

Time frame

24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Heart Centre Singapore

Lead sponsor

Source ClinicalTrials.gov

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