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Cardiovascular Disease Cohort

Cognitive Dysfunction in Cardiovascular Patients Based on Resting fMRI

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05309824
Enrollment
0
Registered
2022-04-04
Start date
2022-04-01
Completion date
2027-03-01
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cognitive Decline

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.

Interventions

None listed

Sponsors

The Affiliated Hospital of Hangzhou Normal University
CollaboratorOTHER
Westlake University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
MMSEBaselineThe investigators assessed orientation (10 points), immediate recall (3 points), attention and computation (5 points), delayed recall (3 points), language function (8 points) (naming, retelling, reading, writing, understanding), and visuospatial perception (1 point). The total score is 30 points, and the demarcation between normal and abnormal is related to education level: the uneducated ≤17 points, the primary school group ≤6 years of education ≤20 points, and the middle school or above group ≤24 points. Below the threshold is cognitive impairment, above is normal.
Digital Sign Conversion TestBaselineThe subjects are required to be familiar with nine different symbols representing the nine numbers from 1 to 9, and then they are asked to fill in the corresponding symbols according to the given numbers as much as possible in the 90s. The exact number recorded is the score.
Reverse digit recitationBaselineA series of 1-9 digits are orally reported to the subject at the rate of one per second. The subject needs to quickly retell the whole string of digits in reverse order after the subject stops counting. The shortest sequence consists of three digits, and there are two sequences of each length. If the subject answers at least one sequence correctly, the sequence length is increased by one, otherwise the test ends. If both sequences of the maximum length that the subject can answer correctly are answered correctly, the length is recorded as the number memory span of the subject; if only one sequence is answered correctly, the length minus 0.5 is recorded as the number memory span of the subject.
N-back taskBaselineSubjects compare the previous stimulus with the NTH stimulus. When n=1, subjects are asked to compare the current stimulus with the previous stimulus adjacent to it. When n=2, the current stimulus is compared with the stimulus in the other position. When n=3, the investigators want to compare the current stimulus with the stimulus two positions away from it. Finally, the response time and discrimination of subjects under different memory loads were counted.
Structural MRIBaselineSagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.
Resting state fMRIBaselineAxial scanning, TR = 2000ms, TE = 30ms, 43 layers, resolution 3.42×3.42, rotation Angle (FA) = 90o, FOV = 240mm, layer thickness = 3.2mm, layer spacing =0mm.
Task state fMRIBaselineAxial scanning, TR = 2000ms, TE = 30ms, 43 layers, resolution 3.42×3.42, rotation Angle (FA) = 90o, FOV = 240mm, layer thickness = 3.2mm, layer spacing =0mm.
Arterial spin labelingBaseline3D pCASL sequence; Thick = 3 mm; 45 layer; TR=4781ms; TE = 11.12 ms; TI=1525ms; The size of axial position matrix is 128×128. Axial image resolution 1.72×1.72 mm2; FA =111 o; Marking time 1500 ms; The total scanning time is 6 minutes and 48 seconds.
Incidence of cardiac eventsAt the 6 monthLong-term cardiac events in this study included stroke, heart failure, acute myocardial infarction and sudden cardiac death.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026