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

NCT04947657 | Recruiting

• 1 other identifier: 2021-462
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Catheter ablation; Coagulation; Atrial Fibrillation burden

Outcome Measures

Primary Outcomes (10)

• 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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• 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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• 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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• 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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• Measure the change in Thrombin Antithrombin levels in relation to atrial fibrillation burden

  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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• Measure the change in Prothrombin time (PT) in relation to atrial fibrillation burden

  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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• Measure the change in Fibrinogen levels in relation to atrial fibrillation burden

  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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• Measure the change in Factor 8 in relation to atrial fibrillation burden

  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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• Measure the change in Factor 11 in relation to atrial fibrillation burden

  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.

  Day 0, Day 1, Day 2, Day 30, Day 90

• Measure the change in D-dimers in relation to atrial fibrillation burden

  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.

  Day 0, Day 1, Day 2, Day 30, Day 90

Secondary Outcomes (10)

• Determine the association between Asymmetric dimethyl arginine (ADMA) 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 B-thromboglobulin 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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (3)

East Jefferson General Hospital

New Orleans, Louisiana, 70006, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Tulane Doctors - Speciality Care - Napoleon

New Orleans, Louisiana, 70115, United States

RECRUITING

Related Publications (14)

• Wu N, Tong S, Xiang Y, Wu L, Xu B, Zhang Y, Ma X, Li Y, Song Z, Zhong L. Association of hemostatic markers with atrial fibrillation: a meta-analysis and meta-regression. PLoS One. 2015 Apr 17;10(4):e0124716. doi: 10.1371/journal.pone.0124716. eCollection 2015.

  PMID: 25884835 BACKGROUND

• Akar JG, Jeske W, Wilber DJ. Acute onset human atrial fibrillation is associated with local cardiac platelet activation and endothelial dysfunction. J Am Coll Cardiol. 2008 May 6;51(18):1790-3. doi: 10.1016/j.jacc.2007.11.083.

  PMID: 18452786 BACKGROUND

• Lim HS, Willoughby SR, Schultz C, Gan C, Alasady M, Lau DH, Leong DP, Brooks AG, Young GD, Kistler PM, Kalman JM, Worthley MI, Sanders P. Effect of atrial fibrillation on atrial thrombogenesis in humans: impact of rate and rhythm. J Am Coll Cardiol. 2013 Feb 26;61(8):852-60. doi: 10.1016/j.jacc.2012.11.046. Epub 2013 Jan 16.

  PMID: 23333141 BACKGROUND

• Ding WY, Gupta D, Lip GYH. Atrial fibrillation and the prothrombotic state: revisiting Virchow's triad in 2020. Heart. 2020 Oct;106(19):1463-1468. doi: 10.1136/heartjnl-2020-316977. Epub 2020 Jul 16.

  PMID: 32675218 BACKGROUND

• Motoki H, Tomita T, Aizawa K, Kasai H, Izawa A, Kumazaki S, Tsutsui H, Koyama J, Ikeda U. Coagulation activity is increased in the left atria of patients with paroxysmal atrial fibrillation during the non-paroxysmal period. Comparison with chronic atrial fibrillation. Circ J. 2009 Aug;73(8):1403-7. doi: 10.1253/circj.cj-09-0008. Epub 2009 Jun 12.

  PMID: 19521017 BACKGROUND

• Skov J, Sidelmann JJ, Bladbjerg EM, Jespersen J, Gram J. Lysability of fibrin clots is a potential new determinant of stroke risk in atrial fibrillation. Thromb Res. 2014 Sep;134(3):717-22. doi: 10.1016/j.thromres.2014.06.031. Epub 2014 Jul 5.

  PMID: 25042725 BACKGROUND

• Katz DF, Maddox TM, Turakhia M, Gehi A, O'Brien EC, Lubitz SA, Turchin A, Doros G, Lei L, Varosy P, Marzec L, Hsu JC. Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline-Recommended Change in Use of the CHADS2 to the CHA2DS2-VASc Score for Thromboembolic Risk Assessment: Analysis From the National Cardiovascular Data Registry's Outpatient Practice Innovation and Clinical Excellence Atrial Fibrillation Registry. Circ Cardiovasc Qual Outcomes. 2017 May;10(5):e003476. doi: 10.1161/CIRCOUTCOMES.116.003476.

  PMID: 28506981 BACKGROUND

• Makowski M, Smorag I, Makowska J, Bissinger A, Grycewicz T, Pasnik J, Kidawa M, Lubinski A, Zielinska M, Baj Z. Platelet reactivity and mean platelet volume as risk markers of thrombogenesis in atrial fibrillation. Int J Cardiol. 2017 May 15;235:1-5. doi: 10.1016/j.ijcard.2017.03.023. Epub 2017 Mar 9.

  PMID: 28302320 BACKGROUND

• Lip GY, Rumley A, Dunn FG, Lowe GD. Plasma fibrinogen and fibrin D-dimer in patients with atrial fibrillation: effects of cardioversion to sinus rhythm. Int J Cardiol. 1995 Oct;51(3):245-51. doi: 10.1016/0167-5273(95)02434-x.

  PMID: 8586473 BACKGROUND

• Otto A, Fareed J, Liles J, Statz S, Walborn A, Rowe T, Jabati S, Hoppensteadt D, Syed MA. Fibrinolytic Deficit and Platelet Activation in Atrial Fibrillation and Their Postablation Modulation. Clin Appl Thromb Hemost. 2018 Jul;24(5):803-807. doi: 10.1177/1076029617750270. Epub 2018 Jan 28.

  PMID: 29374968 BACKGROUND

• Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):474-80. doi: 10.1161/CIRCEP.109.849638. Epub 2009 Aug 4.

  PMID: 19843914 BACKGROUND

• Van Gelder IC, Healey JS, Crijns HJGM, Wang J, Hohnloser SH, Gold MR, Capucci A, Lau CP, Morillo CA, Hobbelt AH, Rienstra M, Connolly SJ. Duration of device-detected subclinical atrial fibrillation and occurrence of stroke in ASSERT. Eur Heart J. 2017 May 1;38(17):1339-1344. doi: 10.1093/eurheartj/ehx042.

  PMID: 28329139 BACKGROUND

• Negreva M, Zarkova A, Prodanova K, Petrov P. Paroxysmal Atrial Fibrillation: Insight Into the Intimate Mechanisms of Coagulation. Cardiol Res. 2020 Feb;11(1):22-32. doi: 10.14740/cr972. Epub 2020 Jan 26.

  PMID: 32095193 BACKGROUND

• Watson T, Shantsila E, Lip GY. Mechanisms of thrombogenesis in atrial fibrillation: Virchow's triad revisited. Lancet. 2009 Jan 10;373(9658):155-66. doi: 10.1016/S0140-6736(09)60040-4.

  PMID: 19135613 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Thrombosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Amitabh Pandey, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayana Bsoul, MD

CONTACT

504-988-3063; mbsoul@tulane.edu

Kunal Sameer, MD, MHA

CONTACT

504-988-3072; ksameer@tulane.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: September 22, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (3)