Cardiovascular Disease Cohort

Cardiovascular Diseases Clinical Trial

Official title:

Cognitive Dysfunction in Cardiovascular Patients Based on Resting fMRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309824
• Other study ID #: 20220303ZJS001
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: March 1, 2027

Study information

• Verified date: May 2023
• Source: Westlake University
• Contact: Ju-sheng Zheng, PhD
• Phone: 86-0571-86915303
• Email: zhengjusheng[@]westlake.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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; ? 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognitive Decline
• Cognitive Dysfunction

Locations

Country	Name	City	State
China	Westlake University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	The Affiliated Hospital of Hangzhou Normal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Structural MRI	Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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