Cardiovascular Disease Cohort

NCT ID: NCT05309824

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2027-03-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Atrial fibrillation

No interventions assigned to this group

Left ventricular hypertrophy

No interventions assigned to this group

Pulmonary hypertension

No interventions assigned to this group

Coronary atherosclerotic heart disease

No interventions assigned to this group

Heart failure with retained ejection fraction

No interventions assigned to this group

Eligibility Criteria

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.

• 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.

• 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.

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

• 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

• 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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role: collaborator

Westlake University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Westlake University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20220303ZJS001

Identifier Type: -

Identifier Source: org_study_id