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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05973474
Other study ID # SYSKY-2023-634-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 30, 2023
Est. completion date July 2024

Study information

Verified date July 2023
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about The Atherogenic Index of Plasma(AIP) in patients with atrial fibrillation(AF). The main questions it aims to answer are: (1)To investigate the correlation between AIP and the occurrence rate of AF. (2) To investigate the correlation between AIP and the occurrence rate of cardiovascular outcome events (MACE events, heart failure, embolism events) in patients with AF. Patients's clinical data including medical history, laboratory tests, and imageological examination will be collected and further analysed.


Description:

Baseline demographic data: age, gender, height, weight, systolic blood pressure, diastolic blood pressure, smoking habit, drinking habit, physical activity, fasting blood glucose, medication use (statins, ACEI/ARB, anticoagulant related drugs), basic medical history (hypertension, diabetes mellitus, coronary heart disease).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 5000
Est. completion date July 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Atrial fibrillation was detected by electrocardiogram or 24-hour holter or portable electrocardiogram monitor; 2. age =18 years old; 3. "low-intermediate" risk group of AF cardioembolic stroke: male patients with CHA2DS2-VASc score 0-1 or female patients with CHA2DS2-VASc score 1-2 Exclusion Criteria: 1. patients with rheumatic heart disease, congenital heart disease, cardiomyopathy, hematological diseases, severe hepatic and renal insufficiency and connective tissue diseases; 2. Echocardiography showed valvular heart disease; 3. patients with transient atrial fibrillation secondary to reversible causes: hyperthyroidism, acute pulmonary embolism, recent surgery, acute myocardial infarction, etc. 4. severe carotid artery stenosis and intracranial artery stenosis; 5. AF patients with recent major surgery. 6. patients with serious lack of clinical data.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type Measure Description Time frame Safety issue
Primary atrial fibrillation (AF) AF diagnoses were ascertained by 3 different sources in our study: ECGs performed at study visits, hospital discharge codes, and death certificates. All ECGs automatically coded as AF were visually checked by a trained cardiologist to confirm AF diagnosis. 10 years
Secondary major adverse cardiovascular events (MACEs) Follow up main adverse cardiovascular and cerebrovascular events such as death, myocardial infarction, stroke, and repeated revascularization. 10 years
Secondary heart failure Patients who required intravenous medications for heart failure after admission (including diuretics, vasodilators, or inotropic agents) or a significant increase in the dose of oral diuretics (i.e., an increase in furosemide of =40mg or equivalent or the addition of a thiazide to a loop diuretic) were considered to have heart failure readmission. Pulmonary rales and/or the third heart sound, chest X-ray, dyspnea, peripheral edema, and NYHA grade were evaluated to further confirm the occurrence of heart failure. 10 years
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