- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05973474
The Atherogenic Index of Plasma(AIP) in Patients With Atrial Fibrillation
July 25, 2023 updated by: zhangkun, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Prognostic Value of the Atherogenic Index of Plasma(AIP)for Cardiovascular Outcomes in Patients With Atrial Fibrillation
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.
Study Overview
Status
Not yet recruiting
Detailed 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).
Study Type
Observational
Enrollment (Estimated)
5000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients diagnosed with AF during hospitalization in our hospital.
Description
Inclusion Criteria:
- Atrial fibrillation was detected by electrocardiogram or 24-hour holter or portable electrocardiogram monitor;
- age ≥18 years old;
- "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:
- patients with rheumatic heart disease, congenital heart disease, cardiomyopathy, hematological diseases, severe hepatic and renal insufficiency and connective tissue diseases;
- Echocardiography showed valvular heart disease;
- patients with transient atrial fibrillation secondary to reversible causes: hyperthyroidism, acute pulmonary embolism, recent surgery, acute myocardial infarction, etc.
- severe carotid artery stenosis and intracranial artery stenosis;
- AF patients with recent major surgery.
- patients with serious lack of clinical data.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
atrial fibrillation (AF)
Time Frame: 10 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major adverse cardiovascular events (MACEs)
Time Frame: 10 years
|
Follow up main adverse cardiovascular and cerebrovascular events such as death, myocardial infarction, stroke, and repeated revascularization.
|
10 years
|
|
heart failure
Time Frame: 10 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 30, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
July 25, 2023
First Submitted That Met QC Criteria
July 25, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSKY-2023-634-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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