NCT04947657 The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study
| NCT ID | NCT04947657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-09-22 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2021-09-22 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Amitabh Pandey, MD
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT04947657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04947657 currently recruiting?
Yes, NCT04947657 is actively recruiting participants. Contact the research team at mbsoul@tulane.edu for enrollment information.
Where is the NCT04947657 trial being conducted?
This trial is being conducted at New Orleans, United States, New Orleans, United States, New Orleans, United States.
Who is sponsoring the NCT04947657 clinical trial?
NCT04947657 is sponsored by Tulane University. The principal investigator is Amitabh Pandey, MD at Tulane University. The trial plans to enroll 20 participants.
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