320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.

April 24, 2024 updated by: Johns Hopkins University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Atrial Fibrillation (AF) is the most common arrhythmia and is associated with significant healthcare-related expenses. With the aging population, the prevalence of AF is increasing. AF frequently co-exists with heart failure (HF) with reduced (HFrEF) or preserved (HFpEF) ejection fraction. The relationship between AF and HF is complex, and one condition constitutes a risk factor for the other. Myocardial interstitial fibrosis is a hallmark of myocardial remodeling occurring as a consequence of risk factor exposure leading to both AF and heart failure. However, the role of interstitial fibrosis in the prognosis of patients with atrial fibrillation with and without heart failure remains unknown.

AF has a significant impact on patients' well-being and quality of life. In addition to coping with uncomfortable symptoms, individuals with this condition face an increased risk of future adverse events like frailty, stroke, dementia, and all-cause mortality. To address these concerns, many patients opt for procedures such as AF ablation, hoping for a cure. While the results of this procedure show promise, a small percentage of patients who undergo AF ablation may experience a recurrence of the arrhythmia or find that the participant's heart's systolic function does not fully recover. The investigators aim is to investigate whether there is a connection between myocardial fibrosis and poor outcomes following AF ablation.

Cardiac MRI (CMR) has been the gold standard methodology of quantification of interstitial fibrosis. Diffuse interstitial fibrosis can be quantified by extracellular volume (ECV) imaging. CMR-based left ventricular ECV has been associated with adverse outcomes in multiple cardiovascular disease states. However, the availability of CMR is confined only to tertiary centers with expertise. Cardiac CT is an alternative way to detect and quantify interstitial fibrosis by quantification of ECV. CT-derived ECV has been shown in multiple studies to have an excellent correlation with CMR-derived ECV. Cardiac CT is widely available and has a higher spatial resolution. Since as part of the standard pre-ablation routine, patients will undergo a cardiac CT scan to accurately map the anatomy of the participant's heart, investigators ought to measure ECV parameters during this visit.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Konstantinos Aronis, MD PHD
  • Phone Number: 2017169226
  • Email: karonis1@jhmi.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Afib with ECV measurement
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.
Diagnostic test: CT
Pre-ablation CT is clinically acquired in patients undergoing catheter ablation. This study entails additional acquisition of the left ventricle to assess extracellular volume (ECV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Atrial Fibrillation
Time Frame: Post procedure up to 90 days
Patients will undergo computed tomography (CT) imaging with a total of 4 CT image acquisition (2 clinical and 2 research) During the follow-up visit with the primary electrophysiologist within 90 days after the procedure, the patient will be assessed for recurrence of atrial fibrillation.
Post procedure up to 90 days
Occurrence of ER visits, hospitalizations for cardiovascular causes
Time Frame: Post procedure up to 90 days
Patients will be assessed for any emergency room visits, or hospitalizations for any cardiovascular causes.
Post procedure up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ejection Fraction
Time Frame: Post procedure up to 90 days
As a follow-up measure, the patient will proceed to have an echocardiogram to check for improvement in ejection fraction. At the end of the study we we will analyze if there are any correlations between ECV expansion and lack of ejection fraction (EF) improvement.
Post procedure up to 90 days
Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
Time Frame: Baseline, Post procedure up to 90 days
Atrial Fibrillation Effect on Quality-of-Life will be used to measure quality of life. The score ranges from 0 to 100, with higher scores indicating better quality of life.
Baseline, Post procedure up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Konstantinos Aronis, MD, PhD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00429859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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