FIBCAG: Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation
Study Details
Study Description
Brief Summary
The purpose of this randomized, controlled trial is to investigate whether coronary computed tomography (CT) angiography and derived treatment (medical anti-ischemic and multimodality treatment and/or mechanical revascularization) prior to catheter ablation improve clinical outcomes in patients with atrial fibrillation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study is an investigator-initiated, prospective, randomized, unblinded, controlled trial to investigate whether coronary CT angiography and derived treatment prior to catheter ablation improves clinical outcomes in patients with atrial fibrillation. The study population will consist of approximately 852 patients aged 18 years and above referred for a catheter ablation treatment for atrial fibrillation at Gentofte Hospital in Denmark. All participants included in the study will have a coronary CT angiography and coronary artery calcium (CAC) scoring performed as an amendment to the standard CT scan of the heart for mapping of the atria prior to catheter ablation. The participants are randomized 1:1 to either have the coronary CT angiography analyzed or not prior to the catheter ablation. According to the result of the coronary CT angiography in the intervention group, subsequent actions may include intensified multimodality medical treatment or referral to invasive coronary angiography and possibly mechanical revascularization according to clinical guidelines. The study will be completed when every participant in the trial has been followed for at least 1.5 years. The primary endpoint is time to first ECG-documented recurrence of atrial fibrillation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Analysis of coronary CT angiography and CAC scoring prior to catheter ablation Based on the results of the coronary CT angiography and CAC scoring in the intervention group, relevant anti-ischemic and multimodality treatment will be initiated according to clinical guidelines. |
Diagnostic Test: Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation
Analysis of coronary CT angiography and CAC scoring and derived treatment prior to catheter ablation.
|
| No Intervention: No analysis of coronary CT angiography and CAC scoring prior to catheter ablation Patients in the control group will follow the current standard of care prior to ablation. |
Outcome Measures
Primary Outcome Measures
- Between-group difference in the time to first ECG-documented recurrence of atrial tachyarrhythmia after catheter ablation [Up to 4.5 years]
Secondary Outcome Measures
- Between-group difference in time to first documented occurrence of other arrhythmias after ablation [Up to 4.5 years]
- Between-group difference in the number of participants hospitalized for angina pectoris and acute coronary syndrome after ablation [Up to 4.5 years]
- Between-group difference in the incidence of acute myocardial infarction after ablation [Up to 4.5 years]
- Between-group difference in the number of patients undergoing revascularization procedures after ablation [Up to 4.5 years]
- Between-group difference in the number of deaths due to cardiovascular disease after ablation [Up to 4.5 years]
- Between-group difference in incidence of stroke after ablation [Up to 4.5 years]
- Between-group difference in incidence of heart failure or heart failure hospitalization after ablation [Up to 4.5 years]
Other Outcome Measures
- Between-group difference in the prevalence of coronary artery disease in patients with atrial fibrillation at baseline [0]
- Between group difference in the quality of life of participants as quantified by a validated self-administered questionnaire [1.5 years]
- The proportion of participants in the active arm that are started or intensified on the following medication following the coronary CT angiography: statins, antithrombotic or antidiabetic medication [1 month]
- Between-group differences in the proportion of patients that are started or intensified on the following medication within 1 year after the coronary CT angiography: statins, antithrombotic, antidiabetic, or antihypertensive medication. [1 year]
- Between-group difference in the number of patients compliant with their prescribed medication 1 and 2 years after the coronary CT angiography as assessed based on a self-administered questionnaire [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age over 18 years
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Referral for catheter ablation treatment (excluding AV-junction ablation) for atrial fibrillation (all types of atrial fibrillation are included - paroxysmal, persistent, long-term persistent and permanent) at the Department of Cardiology at Gentofte Hospital. Both first ablation and re-ablation treatments are included.
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The ability and willingness to provide written informed consent
Exclusion Criteria:
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Known atherosclerotic cardiovascular disease (ASCVD)
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Ongoing treatment with statins
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Contraindications for coronary CT angiography, e.g. contrast allergy
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Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Hellerup | Region Hovedstaden | Denmark | 2900 |
Sponsors and Collaborators
- Tor Biering-Sørensen
Investigators
- Study Chair: Tor Biering-Sørensen, MD, PhD, MPH, MSc, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FIBCAG