The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

Tulane University

Status: Enrolling

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT04947657

2021-462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients, male or female and older than 18 years of age.
• Patients diagnosed with persistent or paroxysmal AF.
• Patients that are undergoing catheter ablation at Tulane University Medical Center.
• Patients that had a cardiac MRI prescribed by their physician as part of their standard of care.

Exclusion criteria

• Patients with coagulation disorders such as, von Willebrand disease, hemophilia, Immune Thrombocytopenic Purpura, etc.
• Patients who are pregnant or breast-feeding or plan to become pregnant during the study period.
• Are not surgically sterile.
• Are of childbearing potential and are unwilling to practice two acceptable methods of birth control.
• Do not plan to continue practicing two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly).
• Patients with mental and/or physical ailments which may prohibit them from actively participating in the study.
• Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.)
• Patients who have a known terminal illness with a prognosis less than 12 months at the time of the informed consent process.
• Planned cardiovascular intervention.
• Patient with diagnosed acute or chronic severe kidney disease or with a low glomerular filtration rate (GFR), <30 mL per minute per 1.73 m2
• Patients who cannot read, speak, and/or understand English.
• Patients with cognitive impairments who are unable to give informed consent.