NCT04947657 · Tulane University
The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study
What this study is 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.
View original scientific description
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.
Primary outcome measures
Measure the change in Asymmetric dimethyl arginine (ADMA) in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between ADMA and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. ADMA will be measured in ng/mL.
Measure the change in markers of platelet activation P-selectin and Platelet factor 4 in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between the markers of platelet activation P-selectin and Platelet factor 4 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. P-selectin and Platelet factor 4 will be measured in ng/mL.
Measure the change in B-thromboglobulin in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between B-thromboglobulin and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. B-thromboglobulin will be measured in µg/L.
Measure the change in coagulation marker Von Willebrand factor in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between coagulation marker Von Willebrand factor and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Von Willebrand factor will be measured in IU/dL.
Measure the change in Thrombin Antithrombin levels in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Thrombin Antithrombin levels and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Thrombin Antithrombin levels will be measured in ng/ml.
Measure the change in Prothrombin time (PT) in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Prothrombin time and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. PT will be measured in seconds.
Measure the change in Fibrinogen levels in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Fibrinogen levels and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Fibrinogen levels will be measured in mg/dL.
Measure the change in Factor 8 in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Factor 8 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Factor 8 will be measured in Percent.
Measure the change in Factor 11 in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Factor 11 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Factor 11 will be measured in U/dL.
Measure the change in D-dimers in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between D-dimers and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. D-dimers will be measured in ng/mL.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New Orleans, Louisiana
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations