Investigating blood biomarkers in patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COAG-AF study aims to explore the relationship between pro-thrombotic biomarkers and atrial fibrillation (AF) burden in patients undergoing catheter ablation. This observational pilot study will involve approximately twenty patients who will have blood samples collected before, during, and after the ablation procedure, alongside cardiac MRI imaging to assess fibrosis. The study will also compare coagulation biomarkers with standard population values and evaluate the impact of ablation on these biomarkers over a three-month period.

Why it matters

Who can join: the full rules

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 it's running

• East Jefferson General Hospital
  New Orleans, Louisiana, United States Recruiting
• University Medical Center
  New Orleans, Louisiana, United States Recruiting
• Tulane Doctors - Speciality Care - Napoleon
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Amitabh Pandey, MD — Tulane University
• Study coordinator: Mayana Bsoul, MD
• Email: mbsoul@tulane.edu
• Phone: 504-988-3063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.