Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Measure the change in Thrombin Antithrombin levels in relation to atrial fibrillation burden
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Measure the change in Thrombin Antithrombin levels in relation to atrial fibrillation burden
时间窗: 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 Asymmetric dimethyl arginine (ADMA) in relation to atrial fibrillation burden
时间窗: 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 coagulation marker Von Willebrand factor in relation to atrial fibrillation burden
时间窗: 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 Prothrombin time (PT) in relation to atrial fibrillation burden
时间窗: 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 Factor 8 in relation to atrial fibrillation burden
时间窗: 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
时间窗: 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
时间窗: 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.
Measure the change in markers of platelet activation P-selectin and Platelet factor 4 in relation to atrial fibrillation burden
时间窗: 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
时间窗: 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 Fibrinogen levels in relation to atrial fibrillation burden
时间窗: 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.
次要结局
- Determine the association between Prothrombin time (PT) and degree of fibrosis in MRI findings(1 Year)
- Determine the association between P-selectin and Platelet factor 4 and degree of fibrosis in MRI findings(1 Year)
- Determine the association between Von Willebrand factor and degree of fibrosis in MRI findings(1 Year)
- Determine the association between Thrombin Antithrombin levels and degree of fibrosis in MRI findings(1 Year)
- Determine the association between D-dimers and degree of fibrosis in MRI findings(1 Year)
- Determine the association between Asymmetric dimethyl arginine (ADMA) and degree of fibrosis in MRI findings(1 Year)
- Determine the association between B-thromboglobulin and degree of fibrosis in MRI findings(1 Year)
- Determine the association between Factor 11 and degree of fibrosis in MRI findings(1 Year)
- Determine the association between Fibrinogen levels and degree of fibrosis in MRI findings(1 Year)
- Determine the association between Factor 8 and degree of fibrosis in MRI findings(1 Year)