Ultra High Resolution CT to Assess Role of Intramyocardial Fat and Delayed Enhancement in Ventricular Arrhythmogenesis

NCT04394637 | Active Not Recruiting

• 1 other identifier: IRB00236647
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to determine how well cardiac computed tomography (CT) scanning measures of fat within the heart can predict abnormal heart rhythms and how well cardiac CT can measure scar within the heart versus cardiac magnetic resonance imaging (MRI).

• People who have been enrolled in PROSe-ICD (NA\_00045142) and Reynolds (NA\_00037404) studies may join
• The procedures, tests, drugs or devices that are part of this research and will be paid for by the study

Conditions

Ventricular Arrhythmias

Keywords

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Prevalence of intramyocardial fat in patients with ischemic heart disease

  The primary aim is to test whether intramyocardial fat on MDCT is as effective or adds additional utility to risk stratification for VA above that of CMR-LGE characteristics in ischemic cardiomyopathy patients who are candidates for ICD therapy or have in situ ICDs. Our objective is to define the prevalence and distribution of intramyocardial fat in patients with ischemic heart disease scheduled for or with in-situ implantable defibrillators. Further, we aim to assess the independent association of intramyocardial fat with VA and determine whether it adds any utility above LGE measured by CMR.

  2 years

• Prevalence of delayed enhanced CT detected scar

  Comparison of the scar distribution on delayed enhanced CT with LGE on cardiac MRI. The significance of our research is that we will test whether delayed enhanced CT can be used as a non-invasive tool for sudden cardiac death risk stratification in patients with ischemic heart disease and whether delayed enhancement CT is comparable to the current non-invasive gold standard of CMR for identifying myocardial scar.

  2 years

• Quantification of delayed enhanced CT detected scar

  Comparison of the scar distribution on delayed enhanced CT with LGE on cardiac MRI. The significance of our research is that we will test whether delayed enhanced CT can be used as a non-invasive tool for sudden cardiac death risk stratification in patients with ischemic heart disease and whether delayed enhancement CT is comparable to the current non-invasive gold standard of CMR for identifying myocardial scar.

  2 years

Study Arms (2)

PROSe-ICD

PROSe-ICD \[NCT00733590/ Institutional Review Board (IRB) NA\_00045142\], a large prospective cohort study of patients who received an ICD for primary prevention.

Reynolds study

Functional Energetics (Reynolds study, NA\_00037404), a study with conventional contrast-enhanced 1H MRI to determine ventricular geometry, global and regional function, as well as infarct size characteristics following delayed contrast enhancement.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will recruit patients with a history of an ischemic cardiomyopathy from the current PROSe-ICD to undergo a cardiac CT performed using an ultra-high-resolution (UHR) CT scanner (Canon, Precision) using iodinated contrast for (a) identification of myocardial fat, and (b) myocardial scar visualization (areas of delayed contrast enhancement).

You may qualify if:

• Patients aged 18 or older with history of ischemic cardiomyopathy enrolled in the current Reynolds study or PROSe-ICD study will be asked to participate
• Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CT
• Ability to understand and willingness to sign the Informed Consent Form

You may not qualify if:

• Known allergy to iodinated contrast media
• Patients with glomerular filtration rate (GFR) ≤ 30 mL/min will not be enrolled in the study due to the use of intravenous iodinated contrast agents
• Atrial fibrillation or uncontrolled tachyarrhythmia
• Evidence of severe symptomatic heart failure (NYHA Class III or IV)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

Johns Hopkins Medical Institute

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Jonathan Chrispin, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: March 4, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)