The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorTulane University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Any AF patient who will undergo first time catheter ablation at Tulane University Medical Center and who is interested in the study will be able to contact the study coordinator for further screening. The investigators anticipate enrolling 20 patients to this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measure the change in Asymmetric dimethyl arginine (ADMA) in relation to atrial fibrillation burden
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.
Time frame
Day 0, Day 1, Day 2, Day 30, Day 902
Measure the change in markers of platelet activation P-selectin and Platelet factor 4 in relation to atrial fibrillation burden
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.
Time frame
Day 0, Day 1, Day 2, Day 30, Day 903
Measure the change in B-thromboglobulin in relation to atrial fibrillation burden
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.
Time frame
Day 0, Day 1, Day 2, Day 30, Day 904
Measure the change in coagulation marker Von Willebrand factor in relation to atrial fibrillation burden
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.
Time frame
Day 0, Day 1, Day 2, Day 30, Day 90Secondary outcomes
1
Determine the association between Asymmetric dimethyl arginine (ADMA) and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Asymmetric dimethyl arginine (ADMA). This will be obtained through the patient's medical history and charts.
Time frame
1 Year2
Determine the association between P-selectin and Platelet factor 4 and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and P-selectin and Platelet factor 4. This will be obtained through the patient's medical history and charts.
Time frame
1 Year3
Determine the association between Von Willebrand factor and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Von Willebrand factor. This will be obtained through the patient's medical history and charts.
Time frame
1 Year4
Determine the association between B-thromboglobulin and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and B-thromboglobulin. This will be obtained through the patient's medical history and charts.
Time frame
1 YearSponsors and contacts
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Source ClinicalTrials.gov