The Cardiovascular-Cognitive Health Initiative
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 4
- 主要终点
- Primary RCT Outcome
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
After obtaining consent, patient's study arm will be revealed via sequentially numbered, opaque, sealed and stapled envelopes.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Main (Observational) Cohort
Required procedures during baseline visit:
i. Blood pressure test ii. Biospecimen collection (Optional) iii. Musculoskeletal analysis iv. Memory test: MoCA and MMSE
Randomized Controlled Trial (RCT) R1 Cohort
Baseline:
- Cardiovascular measurements:-
- Blood pressure test
- Echocardiography
- Electrocardiography
- Biospecimen collection
- Six-minute walk test
- Musculoskeletal Analysis
- Cardiopulmonary exercise test (CPET) / Treadmill test (TMX)
- Magnetic resonance imaging
- Neuropsychological assessment
During Intervention:
12 exercise sessions and 12 cognitive sessions
Post-Intervention:
- Same procedures as Baseline except CPET / TMX
- Post-intervention questionnaire
- Qualitative interview (Optional)
干预措施: Structured cognitive and cardiovascular interventions (Other)
Randomized Controlled Trial (RCT) R2 Cohort
Baseline:
- Cardiovascular measurements:-
- Blood pressure test
- Echocardiography
- Electrocardiography
- Biospecimen collection
- Six-minute walk test
- Musculoskeletal Analysis
- Cardiopulmonary exercise test (CPET) / Treadmill test (TMX)
- Magnetic resonance imaging
- Neuropsychological assessment
Post-Intervention:
- Same procedures as Baseline, except CPET / TMX
- Post-intervention questionnaire
结局指标
主要结局
Primary RCT Outcome
时间窗: 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.
次要结局
未报告次要终点