Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399666
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-30
Brief Title:
Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation
Sponsor:
Vrinnevi Hospital
Organization:
Vrinnevi Hospital
Study Overview
Official Title:
Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IERV
Brief Summary:
Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV Previous studies have primarily focused on high-sensitivity CRP hsCRP CRP and IL-6 while other inflammatory indexes and gene scores might hold greater value
This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation planned for electrical cardioversion and ampgt18 years at two medium-sized hospitals in Sweden Blood samples will be collected prior to electrical cardioversion and at 7- 30- 90- and 180-days follow-up Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG
An interim analysis will be conducted after more than 80 patients have been included If the results from univariate andor multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant the study will be concluded
This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation planned for electrical cardioversion and ampgt18 years at two medium-sized hospitals in Sweden Blood samples will be collected prior to electrical cardioversion and at 7- 30- 90- and 180-days follow-up Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG
An interim analysis will be conducted after more than 80 patients have been included If the results from univariate andor multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant the study will be concluded
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None