Cognitive DeclineNCT05309824
Cardiovascular Disease Cohort
An observational study of Cognitive Decline and Cardiovascular Diseases, run by Westlake University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Decline, Cardiovascular Diseases
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Mar 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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;
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- Sign informed consent to participate in the study voluntarily.
- 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.
- 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.
- 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.
Who cannot join
- 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
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- 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
- 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.
- Patients with coronary atherosclerotic heart disease
- 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.
- Heart failure with retained ejection fraction patients
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Dysfunction in Cardiovascular Patients Based on Resting fMRI
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
- Medical subject headings
- Cognitive Dysfunction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Not described | |
| Left ventricular hypertrophy | Not described | |
| Pulmonary hypertension | Not described | |
| Coronary atherosclerotic heart disease | Not described | |
| Heart failure with retained ejection fraction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Structural MRI
Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Why it stopped: The study was stopped due to the COVID-19 situation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Hangzhou Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309824
- Sponsor's protocol ID
- 20220303ZJS001
- Status last verified
- May 2025
- First submitted
- 24 Mar 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunction in Cardiovascular Patients Based on Resting fMRI
- ClinicalTrials.gov ID
- NCT05309824
- Acronym / sponsor ID
- 20220303ZJS001
- Conditions
- Cognitive Decline, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to the COVID-19 situation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Hangzhou Normal University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | – |
| Left ventricular hypertrophy | – | – |
| Pulmonary hypertension | – | – |
| Coronary atherosclerotic heart disease | – | – |
| Heart failure with retained ejection fraction | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (29 listed)
- Left ventricular hypertrophy patients
- Pulmonary hypertension patients
- Patients with coronary atherosclerotic heart disease
- Heart failure with retained ejection fraction patients
- Severe cervical and cerebrovascular events, such as severe carotid artery plaque or stenosis (stenosis rate greater than 50%), cerebral ischemic stroke, etc;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMSE
Time frame: Baseline
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.
MMSE
Time frame: At the 6 month
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.
MMSE
Time frame: At the 12 month
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.
Digital Sign Conversion Test
Time frame: Baseline
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.
Digital Sign Conversion Test
Time frame: At the 6 month
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.
Digital Sign Conversion Test
Time frame: At the 12 month
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.
Reverse digit recitation
Time frame: Baseline
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.
Reverse digit recitation
Time frame: At the 6 month
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.
Reverse digit recitation
Time frame: At the 12 month
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.
N-back task
Time frame: Baseline
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.
N-back task
Time frame: At the 6 month
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.
N-back task
Time frame: At the 12 month
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.
Structural MRI
Time frame: Baseline
Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.
Structural MRI
Time frame: At the 6 month
Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.
Structural MRI
Time frame: At the 12 month
Sagittal scan, TR = 8.16ms, TE = 3.18ms, FA= 8O, data size: 256×256×1176, resolution 1×1×1mm3.
Resting state fMRI
Time frame: Baseline
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.
Resting state fMRI
Time frame: At the 6 month
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.
Resting state fMRI
Time frame: At the 12 month
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.
Task state fMRI
Time frame: Baseline
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.
Task state fMRI
Time frame: At the 6 month
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.
Task state fMRI
Time frame: At the 12 month
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.
Arterial spin labeling
Time frame: Baseline
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.
Arterial spin labeling
Time frame: At the 6 month
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.
Arterial spin labeling
Time frame: At the 12 month
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.
Incidence of cardiac events
Time frame: At the 6 month
Long-term cardiac events in this study included stroke, heart failure, acute myocardial infarction and sudden cardiac death.
Incidence of cardiac events
Time frame: At the 12 month
Long-term cardiac events in this study included stroke, heart failure, acute myocardial infarction and sudden cardiac death.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline and Cardiovascular Diseases, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: Baseline). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.