Using CT to Measure Heart Fibrosis in Atrial Fibrillation Patients Before Ablation
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.
This study tests if measuring heart tissue changes with a CT scan can help predict how well people with Atrial Fibrillation will do after a heart procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06308094 on ClinicalTrials.gov |
What this trial studies
This study investigates the link between myocardial fibrosis and outcomes in patients with Atrial Fibrillation (AF) undergoing catheter ablation. It utilizes Cardiac CT to measure left ventricular extracellular volume (ECV) as a potential indicator of fibrosis. The research aims to determine if higher ECV levels are associated with increased risks of AF recurrence, hospitalization, and poor recovery of cardiac function. By establishing this relationship, the study could influence treatment strategies for AF based on ECV measurements.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with symptomatic paroxysmal or persistent atrial fibrillation who are suitable for ablation.
Not a fit: Patients with known allergies to iodinated contrast media or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for poor outcomes after AF ablation, leading to more personalized treatment approaches.
How similar studies have performed: While the use of ECV as a prognostic tool in AF is relatively novel, similar studies have shown promise in other cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be at least 21 years old at the time of enrollment. * Patients must be able to give informed consent. * Patients with symptomatic paroxysmal/persistent atrial fibrillation (AF). * Eligible patients must be determined to be suitable candidates for ablation to treat AF by their cardiologist and/or electrophysiologists regardless of this protocol. * Patients are scheduled to have a pre-procedure cardiac CT upon the discretion of their electrophysiologists Exclusion Criteria: * Known allergy to iodinated contrast media. * Elevated serum creatinine (\> 1.5mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula). * Patients with a positive urine or serum pregnancy test will be excluded from this study. * Patients with heart transplantation. * Patients with polymorphic ventricular tachycardia (VT) or presenting in electrical storm. * Presence of any other history or condition that the investigator feels would be problematic. * Patient with iodinated contrast administration for other reason 24 hours prior to investigational CT. * Patients who have a heart pacemaker, metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, mechanical heart valves and prosthetics that contain metal. * Patients with severe claustrophobia.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Konstantinos Aronis, MD, PhD — Johns Hopkins School of Medicine
- Study coordinator: Konstantinos Aronis, MD PHD
- Email: karonis1@jhmi.edu
- Phone: 2017169226
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.