Clinical trial NCT05309824: Cardiovascular Disease Cohort
Official title: Cognitive Dysfunction in Cardiovascular Patients Based on Resting fMRI
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cognitive Decline
Cardiovascular Diseases
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Hangzhou Normal University
First posted: 2022-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with five types of cardiovascular diseases (atrial fibrillation, left ventricular hypertrophy, pulmonary hypertension, coronary heart disease, and heart failure with retained ejection fraction) are planned to be enrolled in the Affiliated Hospital of Hangzhou Normal University.

Brief summary: The Cardiovascular Disease Cohort study is a prospective cohort study among cardiovascular disease patients enrolled in the Affiliated Hospital of Hangzhou Normal University. The primary aim of this study is to explore the brain mechanism of cognitive decline in cardiovascular disease patients using RS-FMRI and multi-omics techniques (including microbiome and metabolomics). Another aim of this study is to develop diagnosis and treatment strategies combining cardiovascular disease 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.

Primary outcomes:
measure: MMSE
timeFrame: Baseline
measure: MMSE
timeFrame: At the 6 month
measure: MMSE
timeFrame: At the 12 month
measure: Digital Sign Conversion Test
timeFrame: Baseline
measure: Digital Sign Conversion Test
timeFrame: At the 6 month
measure: Digital Sign Conversion Test
timeFrame: At the 12 month
measure: Reverse digit recitation
timeFrame: Baseline
measure: Reverse digit recitation
timeFrame: At the 6 month
measure: Reverse digit recitation
timeFrame: At the 12 month
measure: N-back task
timeFrame: Baseline
measure: N-back task
timeFrame: At the 6 month
measure: N-back task
timeFrame: At the 12 month
measure: Structural MRI
timeFrame: Baseline
measure: Structural MRI
timeFrame: At the 6 month
measure: Structural MRI
timeFrame: At the 12 month
measure: Resting state fMRI
timeFrame: Baseline
measure: Resting state fMRI
timeFrame: At the 6 month
measure: Resting state fMRI
timeFrame: At the 12 month
measure: Task state fMRI
timeFrame: Baseline
measure: Task state fMRI
timeFrame: At the 6 month
measure: Task state fMRI
timeFrame: At the 12 month
measure: Arterial spin labeling
timeFrame: Baseline
measure: Arterial spin labeling
timeFrame: At the 6 month
measure: Arterial spin labeling
timeFrame: At the 12 month
measure: Incidence of cardiac events
timeFrame: At the 6 month
measure: Incidence of cardiac events
timeFrame: At the 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
References: