CT for Atrial Fibrillation

Overseen By Konstantinos Aronis, MD PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Heart transplant, Severe claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how fibrosis, a type of heart tissue damage, affects individuals with atrial fibrillation (AF) undergoing catheter ablation. Researchers use a special heart scan, called a Cardiac CT (320-detector Computed Tomography), to measure fibrosis levels and determine if higher levels lead to more AF episodes or hospital visits. The goal is to assess whether this scan can help doctors select better treatments for AF patients. Individuals who frequently experience noticeable AF symptoms and are scheduled for ablation might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to research that could enhance future AF treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that Cardiac CT is safe for measuring ECV in patients with Atrial Fibrillation?

Research has shown that 320-detector CT scans are generally safe for people, including those with heart devices like pacemakers. One study found that patients with these devices usually handle CT imaging well. Other research indicates that 320-slice CT scans provide clear images of the heart and blood vessels, aiding doctors in making informed decisions without causing harm. Although CT scans expose patients to some radiation, studies suggest the levels are low enough to be safe. Overall, evidence supports that this type of CT scan is a reliable and safe method for assessing heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 320-detector Computed Tomography (CT) for atrial fibrillation because it's a cutting-edge approach that provides detailed imaging of the heart. Unlike traditional methods that rely on standard imaging techniques, this advanced CT technology allows for precise measurement of extracellular volume (ECV), which might help in understanding the relationship between ECV expansion and the severity of atrial fibrillation. This could lead to more tailored treatments and better outcomes for patients undergoing catheter ablation, offering insights that current standard care options don't provide.

What evidence suggests that using Cardiac CT to measure ECV is effective for assessing atrial fibrillation outcomes?

Research has shown that the 320-detector CT scan effectively images the heart. It provides clear pictures of the heart's blood vessels, allowing doctors to identify issues without more invasive tests. In this trial, patients with atrial fibrillation (AF) referred for catheter ablation will undergo additional CT acquisition to measure extracellular volume (ECV). This type of CT scan accurately helps doctors check for heart disease and other problems. Its high-quality images and low radiation make it a safe and reliable tool for examining the heart in AF patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Konstantinos Aronis, MD, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 21 with symptomatic paroxysmal/persistent atrial fibrillation (AF), who are candidates for ablation treatment as determined by their cardiologist or electrophysiologist. They must be scheduled for a pre-procedure cardiac CT and able to give informed consent.

Inclusion Criteria

I am capable of understanding and agreeing to the trial's terms.

I am at least 21 years old.

I have irregular heartbeats that come and go or stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Assessment

Participants undergo cardiac CT scan to measure ECV as part of the standard pre-ablation routine

1 day

1 visit (in-person)

Procedure

Participants undergo catheter ablation for atrial fibrillation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of atrial fibrillation and other cardiovascular outcomes

Up to 90 days

Follow-up visit with primary electrophysiologist

What Are the Treatments Tested in This Trial?

Interventions

• 320-detector Computed Tomography

Trial Overview The study tests if Cardiac CT can measure left ventricular extracellular volume (ECV) to indicate myocardial fibrosis in AF patients. It will explore whether higher ECV levels before catheter ablation predict worse outcomes like AF recurrence or poor heart function recovery.

How Is the Trial Designed?

Group I: Afib with ECV measurement Experimental Treatment 1 Intervention

patients who are referred for catheter ablation will undergo additional CT acquisition for measurement of ECV to determine if there is any association between ECV expansion and Afib burden.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Canon Medical Systems, USA

Industry Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

CT coronary angiography using a 256-row detector scanner provides high diagnostic image quality in patients with atrial fibrillation, achieving a 98.2% evaluable rate of coronary artery segments.

The study demonstrated that the effective radiation dose was relatively low (3.05 mSv on average), and heart rate or heart rate variability did not significantly affect image quality, indicating the safety and efficacy of this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Study of Computed Tomography Coronary Angiography Within a Single Cardiac Cycle in Patients With Atrial Fibrillation Using 256-Row Detector Computed Tomography. Wen, B., Xu, L., Liang, J., et al.[2018]

In a study of 30 patients with atrial fibrillation, using prospective ECG-triggered dual-source CT angiography resulted in diagnostic image quality in 97.9% of coronary segments, with the best quality observed at the 300-millisecond reconstruction phase.

The method allowed for a low average radiation dose of 6.5 mSv while achieving excellent inter-reader agreement (98.4% concordance) in detecting significant coronary artery stenosis, indicating its efficacy and reliability for evaluating coronary artery disease in patients with irregular heart rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective-triggered sequential dual-source end-systolic coronary CT angiography for patients with atrial fibrillation: a feasibility study. Srichai, MB., Barreto, M., Lim, RP., et al.[2016]

A study involving 164 patients with atrial fibrillation demonstrated that whole-heart coverage coronary CT angiography (CCTA) achieved a high coronary evaluability rate of 98.4%, indicating excellent image quality for assessing coronary arteries.

The use of this advanced CT scanner did not increase radiation exposure, maintaining similar effective doses for patients with low and high heart rates, suggesting it is a safe imaging option for patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image quality and radiation dose of coronary CT angiography performed with whole-heart coverage CT scanner with intra-cycle motion correction algorithm in patients with atrial fibrillation. Andreini, D., Pontone, G., Mushtaq, S., et al.[2020]

320-detector CT coronary angiography (CTCA) is a feasible and accurate method for diagnosing coronary artery disease (CAD) in patients with atrial fibrillation, showing high sensitivity (90.0%) and specificity (99.3%) based on a study of 37 patients.

The radiation dose from 320-detector CTCA was measured at an effective dose of 13.0 ± 4.7 mSv, which is important for assessing the safety of this imaging technique in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 320-detector CT coronary angiography in patients with atrial fibrillation: preliminary results. Xu, L., Yang, L., Fan, Z., et al.[2022]

In a study of 75 patients with atrial fibrillation undergoing coronary CT angiography, the image quality was comparable to that of 75 control patients in sinus rhythm, indicating that effective imaging can be achieved even in patients with irregular heartbeats.

However, the radiation dose for patients with atrial fibrillation was significantly higher, approximately 1.8 times greater than that for patients in sinus rhythm, highlighting a safety concern regarding increased radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective ECG-gated coronary 320-MDCT angiography with absolute acquisition delay strategy for patients with persistent atrial fibrillation. Kondo, T., Kumamaru, KK., Fujimoto, S., et al.[2016]

In a study of 303 patients undergoing coronary CT angiography (CCTA), the standard-dose protocol provided significantly better image quality and observer confidence compared to the low-dose protocol, with a 20% reduction in image quality for low-dose scans.

The low-dose CCTA protocol reduced radiation exposure by 50%, making it a safer option for younger patients, while the standard-dose protocol is recommended for older patients or those suspected of having coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary CT angiography in patients with atrial fibrillation: Standard-dose and low-dose imaging with a high-resolution whole-heart CT scanner. Matveeva, A., Schmitt, RR., Edtinger, K., et al.[2020]

In a study of 142 patients (71 with chronic atrial fibrillation and 71 in normal sinus rhythm), single heartbeat 640-slice coronary CT angiography (CCTA) achieved diagnostic image quality in 96.4% of segments for those with atrial fibrillation, although 14% had at least one non-diagnostic segment compared to 2.8% in the normal rhythm group.

The mean effective radiation dose for patients with atrial fibrillation was significantly higher (4.24 mSv) than for those in normal sinus rhythm (2.67 mSv), indicating a 59% increase in radiation exposure for the cAF group, although the imaging protocol was still feasible for patients with heart rates below 72 bpm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image quality and radiation dose of single heartbeat 640-slice coronary CT angiography: a comparison between patients with chronic atrial fibrillation and subjects in normal sinus rhythm by propensity analysis. Di Cesare, E., Gennarelli, A., Di Sibio, A., et al.[2022]

CT coronary angiography demonstrates high diagnostic accuracy in patients with atrial fibrillation, showing sensitivity of 94% and specificity of 91% when compared to conventional coronary angiography, based on a systematic review of 7 studies involving 247 patients.

However, the procedure results in a significantly higher radiation dose (mean difference of 4.03 mSv) for patients with atrial fibrillation compared to those with sinus rhythm, although the older age of these patients may reduce concerns about long-term cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy and radiation dose of CT coronary angiography in atrial fibrillation: systematic review and meta-analysis. Vorre, MM., Abdulla, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21153826/

Diagnostic performance of 320-detector CT coronary ... Conclusion: 320-detector CTCA is feasible and accurate in excluding CAD in patients with AF. MeSH terms. Aged; Atrial Fibrillation / diagnosis; Atrial ...

2. jacc.org jacc.org/doi/10.1016/S0735-1097%2813%2960909-2

A MULTICENTER STUDY OF 320 SLICE COMPUTED ... 53 consecutive CAF patients underwent both 320 slice CT and CAG within 3 months (43 male; 69 ± 9 yrs; CHADS2 score 2.2 ± 1.3; CHA2DS2-VASc score 3.5 ± 1.6) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3184392/

Diagnostic performance of 320-slice multidetector ... 320-slice CTA allows accurate non-invasive assessment of significant graft, recipient vessel and nongrafted vessel stenosis in patients with prior CABG.

4. ajronline.org ajronline.org/doi/10.2214/AJR.09.2319

Image Quality of Coronary 320-MDCT in Patients With Atrial ... The overall mean image quality score for all three coronary arteries in atrial fibrillation was 1.25 ± 0.47 (SD) and 1.08 ± 0.26 in sinus rhythm (p < 0.001).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633218303702

Low-Dose Coronary CT Angiography in Patients with Atrial ... The novel whole-heart coverage CT scanner allows evaluating coronary arteries with high image quality and low radiation exposure in patients with AF and high HR ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5152998/

Computed Tomography Imaging in Atrial Fibrillation Ablation The purpose of this review is to evaluate the utility of computed tomography (CT) imaging in guiding radiofrequency catheter ablation (RFCA).

7. sciencedirect.com sciencedirect.com/science/article/pii/S0735109714010973

Safety of Computed Tomography in Patients With Cardiac ... Computed tomography (CT) imaging has been traditionally considered to be safe in patients with cardiac rhythm management (CRM) devices such as permanent ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03324308

Dynamic Computed Tomography Myocardial Perfusion ... In this study the investigators aim to evaluate the feasibility, safety and accuracy of the low-radiation dose dynamic myocardial CT perfusion compared to ...