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 study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies.

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.

Is 320-detector CT safe for humans?

Studies on CT coronary angiography using 320-detector CT in patients with atrial fibrillation have focused on evaluating image quality and radiation dose, indicating that the procedure is feasible with manageable radiation exposure. ^{1 2 3 4 5}

How does CT coronary angiography differ from other treatments for atrial fibrillation?

CT coronary angiography is unique because it uses advanced imaging technology to visualize the heart's blood vessels in patients with atrial fibrillation, providing detailed images in a single heartbeat with lower radiation doses compared to traditional methods. This approach helps in accurately diagnosing heart conditions associated with atrial fibrillation. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment 320-detector Computed Tomography for Atrial Fibrillation?

Research shows that 320-detector CT is effective in providing accurate images of the heart in patients with atrial fibrillation, which helps doctors diagnose and plan treatment. It also has a manageable radiation dose, making it a safe option for patients. ^{2 3 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

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]

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]

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]

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]

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]

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 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 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]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 320-detector CT coronary angiography in patients with atrial fibrillation: preliminary results. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Ireland 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. [2022]

4. Germany 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective ECG-gated coronary 320-MDCT angiography with absolute acquisition delay strategy for patients with persistent atrial fibrillation. [2016]

6. United States 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. [2018]

7. Germany 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Prospective-triggered sequential dual-source end-systolic coronary CT angiography for patients with atrial fibrillation: a feasibility study. [2016]