NCT05973474

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 25, 2023

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • major adverse cardiovascular events (MACEs)

    10 years

  • heart failure

    10 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with AF during hospitalization in our hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationLipid Metabolism DisordersCardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 3, 2023

Study Start

July 30, 2023

Primary Completion

March 1, 2024

Study Completion

July 1, 2024

Last Updated

August 3, 2023

Record last verified: 2023-07