Exploring cognitive decline in cardiovascular disease patients

Cognitive Dysfunction in Cardiovascular Patients Based on Resting fMRI

This study is trying to understand how heart problems like atrial fibrillation and thickened heart muscles affect thinking and memory in patients, while also looking for better ways to treat both heart and brain health.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Westlake University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05309824 on ClinicalTrials.gov

What this trial studies

The Cardiovascular Disease Cohort is a prospective observational study focusing on patients with cardiovascular diseases, particularly those with atrial fibrillation and left ventricular hypertrophy. It aims to investigate the brain mechanisms underlying cognitive decline in these patients using advanced techniques such as resting-state functional MRI (RS-FMRI) and multi-omics approaches, including microbiome and metabolomics analysis. The study also seeks to develop integrated diagnostic and treatment strategies that address both cardiovascular health and cognitive function.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 45-80 years diagnosed with atrial fibrillation or left ventricular hypertrophy.

Not a fit: Patients with valvular atrial fibrillation, severe liver or kidney failure, malignant tumors, blood system diseases, or recent major surgical trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients suffering from both cardiovascular diseases and cognitive decline.

How similar studies have performed: While the specific combination of cognitive decline and cardiovascular disease in this context may be novel, similar studies have shown promise in exploring the links between cardiovascular health and cognitive function.

Eligibility criteria

1. Atrial fibrillation patients

   Inclusion Criteria:
   * Age: 45-80 years old;
   * Consistent with the diagnosis of atrial fibrillation: standard 12-lead ECG recording or ≥30s single-lead ECG recording or 24-hour dynamic electrocardiogram, no obvious repeated P wave, irregular RR interval (when it does not damage atrioventricular conduction) can be diagnosed as clinical atrial fibrillation;
   * Anticoagulant therapy was selected according to cha2DS2-VASC score and HASBLED score;
   * Voluntarily participate in the study and sign the informed consent.

   Exclusion Criteria:
   * Valvular atrial fibrillation, atrial fibrillation caused by hyperthyroidism;
   * Severe liver and kidney failure;
   * Malignant tumor;
   * Diseases of the blood system;
   * History of major surgical trauma within six months.
2. Left ventricular hypertrophy patients

   Inclusion Criteria:
   * Age: 45-80 years old;
   * ECG diagnosis of left ventricular hypertrophy: increased QRS group voltage: CHEST lead Rv5 or Rv6\>2.5mV; Rv5+Sv1\>4.0mV (male) or \>3.5mV (female) Or in the limb lead, R1\>11.5 mV; RaVL \> 1.2 mV; RaVF \> 2.0 mV; RI + SIII \> 2.5 mV;
   * Sign informed consent to participate in the study voluntarily.

   Exclusion Criteria:
   * Left ventricular hypertrophy caused by valvular heart disease and hyperthyroidism;
   * Severe liver and kidney failure;
   * Malignant tumor;
   * Diseases of the blood system;
   * History of major surgical trauma within six months.
3. Pulmonary hypertension patients

   Inclusion Criteria:
   * Age: 18-80 years;
   * Consistent with the diagnosis of pulmonary hypertension: at sea level and resting state, average pulmonary arterial pressure (mPAP) ≥25 mmHg (1mmHg=0.133kPa) measured by right heart catheter, or pulmonary arterial pressure ≥35 mmHg estimated by tricuspid regurgitation velocity indicated by cardiac ultrasound;
   * Sign informed consent to participate in the study voluntarily.

   Exclusion Criteria:
   * Patients with other serious cardiovascular and cerebrovascular diseases;
   * Severe liver and kidney failure;
   * Malignant tumor;
   * Diseases of the blood system;
   * History of major surgical trauma within six months.
4. Patients with coronary atherosclerotic heart disease

   Inclusion Criteria:
   * Age: 45-80 years old;
   * In line with the diagnosis of coronary heart disease: coronary artery stenosis indicated by CORONARY CTA or angiography, with a severity of more than 50%, accompanied by symptoms of chest distress and chest pain;
   * Sign informed consent to participate in the study voluntarily.

   Exclusion Criteria:
   * Severe valvular heart disease, hyperthyroidism, etc;
   * Severe liver and kidney failure;
   * Malignant tumor;
   * Diseases of the blood system;
   * History of major surgical trauma within six months.
5. Heart failure with retained ejection fraction patients

Inclusion Criteria:

* Age: 45-80 years;
* Patients with HFpEF diagnosis had clinical symptoms or signs of cardiac insufficiency, cardiac echocardiography suggested left ventricular eject fraction (LVEF≥50%), increased natriuretic peptide, and met at least one of the following criteria: a. Left ventricular hypertrophy and/or left atrium enlargement; B. Abnormal diastolic function of the heart.
* It is necessary to rule out that the patient's symptoms are not caused by heart disease; ④ Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

* Severe cervical and cerebrovascular events, such as severe carotid artery plaque or stenosis (stenosis rate greater than 50%), cerebral ischemic stroke, etc;
* Severe liver and kidney failure;
* Malignant tumor;
* Diseases of the blood system;
* History of major surgical trauma within six months.

Where this trial is running

Hangzhou, Zhejiang

• Westlake University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ju-sheng Zheng, PhD

Conditions Cognitive Decline; Cardiovascular Diseases