Investigating blood biomarkers in patients with atrial fibrillation
Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study
This study is testing how certain blood markers relate to atrial fibrillation in patients getting heart surgery and if the surgery changes these markers over three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 3 sites (New Orleans, Louisiana and 2 other locations) |
| Trial ID | NCT04947657 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with persistent or paroxysmal atrial fibrillation who are scheduled for catheter ablation.
Not a fit: Patients with coagulation disorders or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of AF and improve patient management by identifying biomarkers that predict AF burden and response to treatment.
How similar studies have performed: While the approach of correlating biomarkers with AF burden is being explored, this specific study's methodology is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Orleans, Louisiana and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.