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Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation (FIBCAG)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation
Sponsored by
Tor Biering-Sørensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Coronary Artery Disease, Coronary Computed Tomography Angiography, Atrial Fibrillation, Ischemic heart disease, Catheter Ablation, Atherosclerosis, Cardiovascular Diseases, Randomized Controlled Trial, Statins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age over 18 years 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. The ability and willingness to provide written informed consent Exclusion Criteria: Known atherosclerotic cardiovascular disease (ASCVD) Ongoing treatment with statins Contraindications for coronary CT angiography, e.g. contrast allergy 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.

Sites / Locations

  • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Analysis of coronary CT angiography and CAC scoring prior to catheter ablation

No analysis of coronary CT angiography and CAC scoring prior to catheter ablation

Arm Description

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.

Patients in the control group will follow the current standard of care prior to ablation.

Outcomes

Primary Outcome Measures

Between-group difference in time to first recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up.

Secondary Outcome Measures

Between-group difference in time to first documented occurrence of other arrhythmias after ablation
Between-group difference in the number of participants hospitalized for angina pectoris and acute coronary syndrome after ablation
Between-group difference in the incidence of acute myocardial infarction after ablation
Between-group difference in the number of patients undergoing revascularization procedures after ablation
Between-group difference in the number of deaths due to cardiovascular disease after ablation
Between-group difference in incidence of stroke after ablation
Between-group difference in incidence of heart failure or heart failure hospitalization after ablation
Between-group difference in number of participants hospitalized for atrial fibrillation after ablation

Full Information

First Posted
July 21, 2023
Last Updated
September 28, 2023
Sponsor
Tor Biering-Sørensen
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1. Study Identification

Unique Protocol Identification Number
NCT05978388
Brief Title
Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation
Acronym
FIBCAG
Official Title
Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2028 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tor Biering-Sørensen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 improve 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 results 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 each patient has been followed for at least 1 year. The primary endpoint is time to first documented recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Coronary Artery Disease, Coronary Computed Tomography Angiography, Atrial Fibrillation, Ischemic heart disease, Catheter Ablation, Atherosclerosis, Cardiovascular Diseases, Randomized Controlled Trial, Statins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
852 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Analysis of coronary CT angiography and CAC scoring prior to catheter ablation
Arm Type
Experimental
Arm Description
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.
Arm Title
No analysis of coronary CT angiography and CAC scoring prior to catheter ablation
Arm Type
No Intervention
Arm Description
Patients in the control group will follow the current standard of care prior to ablation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation
Intervention Description
Analysis of coronary CT angiography and CAC scoring and derived treatment prior to catheter ablation.
Primary Outcome Measure Information:
Title
Between-group difference in time to first recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Between-group difference in time to first documented occurrence of other arrhythmias after ablation
Time Frame
Up to 4 years
Title
Between-group difference in the number of participants hospitalized for angina pectoris and acute coronary syndrome after ablation
Time Frame
Up to 4 years
Title
Between-group difference in the incidence of acute myocardial infarction after ablation
Time Frame
Up to 4 years
Title
Between-group difference in the number of patients undergoing revascularization procedures after ablation
Time Frame
Up to 4 years
Title
Between-group difference in the number of deaths due to cardiovascular disease after ablation
Time Frame
Up to 4 years
Title
Between-group difference in incidence of stroke after ablation
Time Frame
Up to 4 years
Title
Between-group difference in incidence of heart failure or heart failure hospitalization after ablation
Time Frame
Up to 4 years
Title
Between-group difference in number of participants hospitalized for atrial fibrillation after ablation
Time Frame
Up to 4 years
Other Pre-specified Outcome Measures:
Title
Between-group difference in the prevalence of coronary artery disease in patients with atrial fibrillation at baseline
Time Frame
0
Title
Between group difference in the quality of life of participants as quantified by a validated self-administered questionnaire
Time Frame
1 year
Title
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
Time Frame
1 month
Title
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.
Time Frame
1 year
Title
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
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years 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. The ability and willingness to provide written informed consent Exclusion Criteria: Known atherosclerotic cardiovascular disease (ASCVD) Ongoing treatment with statins Contraindications for coronary CT angiography, e.g. contrast allergy 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Espersen, MD
Phone
+4551180082
Email
caroline.espersen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tor Biering-Sørensen, MD, PhD, MPH, MSc
Phone
+4528933590
Email
tor.biering-soerensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Biering-Sørensen, MD, PhD, MPH, MSc
Organizational Affiliation
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
City
Hellerup
State/Province
Region Hovedstaden
ZIP/Postal Code
2900
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Espersen, MD
Phone
+4551180082
Email
caroline.espersen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Tor Biering-Sørensen, MD, PhD, MPH, MSc
Phone
+4528933590
Email
tor.biering-soerensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Caroline Espersen, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Please contact the sponsor-investigator in case of any inquiries.

Learn more about this trial

Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation

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