Cardiovascular Disease Cohort

NCT05309824 | Withdrawn DMC

• 1 other identifier: 20220303ZJS001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (26)

• MMSE

  The 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.

  Baseline

• MMSE

  The 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.

  At the 6 month

• MMSE

  The 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.

  At the 12 month

• Digital Sign Conversion Test

  The 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.

  Baseline

• Digital Sign Conversion Test

  The 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.

  At the 6 month

• Digital Sign Conversion Test

  The 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.

  At the 12 month

• Reverse digit recitation

  A 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.

  Baseline

• Reverse digit recitation

  A 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.

  At the 6 month

• Reverse digit recitation

  A 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.

  At the 12 month

• N-back task

  Subjects 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.

  Baseline

• N-back task

  Subjects 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.

  At the 6 month

• N-back task

  Subjects 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.

  At the 12 month

• Structural MRI

  Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.

  Baseline

• Structural MRI

  Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.

  At the 6 month

• Structural MRI

  Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.

  At the 12 month

• Resting state fMRI

  Axial 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.

  Baseline

• Resting state fMRI

  Axial 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.

  At the 6 month

• Resting state fMRI

  Axial 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.

  At the 12 month

• Task state fMRI

  Axial 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.

  Baseline

• Task state fMRI

  Axial 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.

  At the 6 month

• Task state fMRI

  Axial 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.

  At the 12 month

• Arterial spin labeling

  3D 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.

  Baseline

• Arterial spin labeling

  3D 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.

  At the 6 month

• Arterial spin labeling

  3D 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.

  At the 12 month

• Incidence of cardiac events

  Long-term cardiac events in this study included stroke, heart failure, acute myocardial infarction and sudden cardiac death.

  At the 6 month

• Incidence of cardiac events

  Long-term cardiac events in this study included stroke, heart failure, acute myocardial infarction and sudden cardiac death.

  At the 12 month

Study Arms (5)

Atrial fibrillation

Left ventricular hypertrophy

Pulmonary hypertension

Coronary atherosclerotic heart disease

Heart failure with retained ejection fraction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Left ventricular hypertrophy patients
• 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.
• 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.
• Pulmonary hypertension patients

Sponsors & Collaborators

• Westlake University: lead
• The Affiliated Hospital of Hangzhou Normal University: collaborator

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310058, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool and saliva samples

MeSH Terms

Conditions

Cognitive Dysfunction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-05

Locations

CN (1)