Recruiting

CoAG Biomarkers

Sponsor:

Tulane University

Code:

NCT04947657

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04947657

Start date

Sep 22, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]
  • 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 ]
  • Measure the change in B-thromboglobulin in relation to atrial fibrillation burden [ Time Frame: 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 [ Time Frame: Day 0, Day 1, Day 2, Day 30, Day 90 ]
  • 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 ]
  • 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 ]
  • Measure the change in Fibrinogen levels in relation to atrial fibrillation burden [ Time Frame: Day 0, Day 1, Day 2, Day 30, Day 90 ]
  • Measure the change in Factor 8 in relation to atrial fibrillation burden [ Time Frame: Day 0, Day 1, Day 2, Day 30, Day 90 ]
  • Measure the change in Factor 11 in relation to atrial fibrillation burden [ Time Frame: Day 0, Day 1, Day 2, Day 30, Day 90 ]
  • Measure the change in D-dimers in relation to atrial fibrillation burden [ Time Frame: Day 0, Day 1, Day 2, Day 30, Day 90 ]

Central Contacts and Locations

Central contacts

Mayana Bsoul, MD

504-988-3063mbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Locations

East Jefferson General Hospital

Recruiting

New Orleans, Louisiana, United States, 70006

Contacts

Mayana Bsoul, MD

504-988-3063mbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Amitabh Pandey, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Mayana Bsoul, MD

504-988-3063mbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Amitabh Pandey, MD

Tulane Doctors - Speciality Care - Napoleon

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Mayana Bsoul, MD

504-988-3063mbsoulmbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Amitabh Pandey, MD

More Information

Sponsor

Tulane University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Catheter ablation
  • Coagulation
  • Atrial Fibrillation burden

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-03-05.