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

Phase

N/A

Condition

Chest Pain

Thrombosis

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT04947657

2021-462

Ages 18-120
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theirstandard of care.

Exclusion

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 thestudy period.
Are not surgically sterile.
Are of childbearing potential and are unwilling to practice two acceptable methodsof birth control.
Do not plan to continue practicing two acceptable methods of birth controlthroughout the trial (highly effective methods of birth control are defined asthose, used alone or in combination, that result in a low failure rate i.e. lessthan 1% per year when used consistently and correctly).
Patients with mental and/or physical ailments which may prohibit them from activelyparticipating in the study.
Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium,pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implantscontraindicated for use of MRI, etc.)
Patients who have a known terminal illness with a prognosis less than 12 months atthe time of the informed consent process.
Planned cardiovascular intervention.
Patient with diagnosed acute or chronic severe kidney disease or with a lowglomerular 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.

Study Design

September 22, 2021

December 31, 2027

Study 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.

Connect with a study center

East Jefferson General Hospital
New Orleans, Louisiana 70006
United States
Active - Recruiting
Tulane Doctors - Speciality Care - Napoleon
New Orleans, Louisiana 70115
United States
Active - Recruiting
Tulane University Medical Center
New Orleans, Louisiana 70112
United States
Active - Recruiting
University Medical Center
New Orleans, Louisiana 70112
United States
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.