Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 8:00 AM
Study NCT ID:
NCT04947657
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study
Sponsor:
Tulane University
Organization:
Study Overview
Official Title:
Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-12
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:
None
Brief Summary:
The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden.
Secondary objectives of the study are the following:
* To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF.
* To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care.
* To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values.
* To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.
Secondary objectives of the study are the following:
* To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF.
* To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care.
* To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values.
* To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.
Detailed Description:
COAG-AF is a 3-month prospective observational study in patients diagnosed with atrial fibrillation and undergoing a first-time ablation procedure. It will be a pilot study consisting of approximately twenty patients.
Patients will undergo a baseline blood draw prior to ablation. A cardiac MRI (LGE-MRI) scan will also be performed prior to ablation and is part of standard of care in patients undergoing ablation.
During catheter ablation, blood will be taken simultaneously from a peripheral blood vessel and from the left atrium (LA) at two different timepoints.
Patients will have additional blood draws immediately following ablation, one month and three months after ablation.
Study Data Elements:
The investigators will collect data from electronic medical health records and/or REDCap surveys sent through e-mail addresses provided by participants: demographic information, medical history, medication use, family history, and health behaviors (smoking, alcohol, eating habits etc.). Imaging data, notably echography and cardiac MRI will be recorded when applicable. Imaging data collected will include:
* LA fibrosis: %, and location.
* Left Ventricular (LV) fibrosis: % and location
* LA shape
* LA volume
* LA functional assessment
* Left ventricular ejection fraction (LVEF)
Chart reviews and surveys will collect the following data:
* All-cause mortality
* Cardiovascular mortality
* Hospitalizations
* Cerebrovascular events
* AF free interval after ablation
* Heart Failure
The investigators will also collect data from an FDA approved ElectroCardioGram (ECG) wearable patch (BodyGuardian® MINI) by Preventice, when prompted. All data elements will be stored on a secured, HIPAA compliant REDCap study database, only accessible by study team members.
Lab Tests:
Venipuncture will be performed by a trained nurse or a trained technician. Blood samples will be collected before ablation, twice during ablation, and after ablation at day 1, 30 and 90 at the Tulane Hospital blood laboratory. During ablation, two samples will be obtained from the LA simultaneously while obtaining peripheral blood. Note that the catheter is already in the LA while performing ablation. Therefore, no additional steps are required to obtain blood samples from LA.
Coagulation biomarkers that will be studied:
* Markers of endothelial dysfunction: Asymmetric dimethyl arginine (ADMA)
* Markers of platelet activation: P-selectin, Platelet factor 4, B-thromboglobulin
* Markers of coagulation: Von Willebrand factor (vWf), Thrombin levels: Thrombin Antithrombin levels (TAT), Prothrombin Factor 1+2, Fibrinogen levels, Factor 8, Factor 11
* Markers of fibrinolysis: D-dimers
ECG Wearable Patch:
Participants will receive an FDA approved BodyGuardian® MINI ECG patch provided by Preventice to wear post- ablation, as part of the patient's standard of care. Duration of ECG Patch will be determined by the treating physician. This will provide a continuous ECG strip to assess the amount of AF burden a patient is in after their procedure. The patch must be worn for the entire period and can be worn during exercise and during showering/bathing. A member of the clinical trial team will help with the application set-up process. They will assign each patient a unique identifier which will be entered into the device at the study site so that the patient's ECG transmissions will always be associated with their participant identifier (ID). These results will be uploaded onto the study data management platform for analysis.
Patients will undergo a baseline blood draw prior to ablation. A cardiac MRI (LGE-MRI) scan will also be performed prior to ablation and is part of standard of care in patients undergoing ablation.
During catheter ablation, blood will be taken simultaneously from a peripheral blood vessel and from the left atrium (LA) at two different timepoints.
Patients will have additional blood draws immediately following ablation, one month and three months after ablation.
Study Data Elements:
The investigators will collect data from electronic medical health records and/or REDCap surveys sent through e-mail addresses provided by participants: demographic information, medical history, medication use, family history, and health behaviors (smoking, alcohol, eating habits etc.). Imaging data, notably echography and cardiac MRI will be recorded when applicable. Imaging data collected will include:
* LA fibrosis: %, and location.
* Left Ventricular (LV) fibrosis: % and location
* LA shape
* LA volume
* LA functional assessment
* Left ventricular ejection fraction (LVEF)
Chart reviews and surveys will collect the following data:
* All-cause mortality
* Cardiovascular mortality
* Hospitalizations
* Cerebrovascular events
* AF free interval after ablation
* Heart Failure
The investigators will also collect data from an FDA approved ElectroCardioGram (ECG) wearable patch (BodyGuardian® MINI) by Preventice, when prompted. All data elements will be stored on a secured, HIPAA compliant REDCap study database, only accessible by study team members.
Lab Tests:
Venipuncture will be performed by a trained nurse or a trained technician. Blood samples will be collected before ablation, twice during ablation, and after ablation at day 1, 30 and 90 at the Tulane Hospital blood laboratory. During ablation, two samples will be obtained from the LA simultaneously while obtaining peripheral blood. Note that the catheter is already in the LA while performing ablation. Therefore, no additional steps are required to obtain blood samples from LA.
Coagulation biomarkers that will be studied:
* Markers of endothelial dysfunction: Asymmetric dimethyl arginine (ADMA)
* Markers of platelet activation: P-selectin, Platelet factor 4, B-thromboglobulin
* Markers of coagulation: Von Willebrand factor (vWf), Thrombin levels: Thrombin Antithrombin levels (TAT), Prothrombin Factor 1+2, Fibrinogen levels, Factor 8, Factor 11
* Markers of fibrinolysis: D-dimers
ECG Wearable Patch:
Participants will receive an FDA approved BodyGuardian® MINI ECG patch provided by Preventice to wear post- ablation, as part of the patient's standard of care. Duration of ECG Patch will be determined by the treating physician. This will provide a continuous ECG strip to assess the amount of AF burden a patient is in after their procedure. The patch must be worn for the entire period and can be worn during exercise and during showering/bathing. A member of the clinical trial team will help with the application set-up process. They will assign each patient a unique identifier which will be entered into the device at the study site so that the patient's ECG transmissions will always be associated with their participant identifier (ID). These results will be uploaded onto the study data management platform for analysis.
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?: