Ventricular ArrhythmiasNCT04394637
Ultra High Resolution CT to Assess Role of Intramyocardial Fat and Delayed Enhancement in Ventricular Arrhythmogenesis
An observational study of Ventricular Arrhythmias, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Arrhythmias
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287
About this study
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
Read the detailed description
The investigators aim to investigate the role of intramyocardial fat on ventricular arrhythmogenesis. Intramyocardial fat deposition has been frequently observed in patients with ischemic heart disease and is readily detectable by multi-detector computed tomography (MDCT) with high sensitivity and specificity, unlike other modalities. Like intramyocardial fat, reentrant ventricular tachycardia (VT) tends to occur late after the onset of myocardial infarction and the investigators hypothesize that lipomatous metaplasia within the infarct may precipitate later onset ventricular arrhythmias (VA). Prior studies have shown that intramyocardial fat correlates with slow myocardial conduction velocity and with critical circuits for VA but the investigators do not know the causal relationship between intramyocardial fat and future risk of VA.
Intramyocardial fat deposition or lipomatous metaplasia has been frequently observed in patients with ischemic heart disease and is readily detectable by multi-detector computed tomography (MDCT) with high sensitivity and specificity. Like intramyocardial fat, reentrant ventricular tachycardia (VT) tends to occur late after the onset of myocardial infarction and the investigators hypothesize that there may be a causal relationship. Prior studies have shown that intramyocardial fat correlates with slow myocardial conduction velocity and with critical circuits for VT in patients referred for VT ablation who already manifest VA.
However, the correlation of intramyocardial fat on CT with late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) in a general population of patients with ischemic cardiomyopathy with no prior history of VA has not been reported. Specifically, it is unknown whether the presence, distribution and/or volume of fat is an independent predictor of VA. Further CMR is less widely available in medical centers, and is more expensive with longer scanning times compared to CT. CT provides higher spatial resolution, is widely available and is not as susceptible to magnetic interference from internal cardiac defibrillator (ICD) generators and thus makes it an attractive imaging modality for risk stratification, particularly longitudinally over time.
Hypothesis: The investigators' 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, the investigators aim to assess the independent association of intramyocardial fat with VA and determine whether it adds any utility above LGE measured by CMR. Finally, the investigators will assess how well delayed enhanced CT correlates with LGE on MRI and test its association with ventricular arrhythmias.
Importance: The significance of the investigators' research is that the investigators will: 1) test whether intramyocardial fat on CT can be used as a non-invasive tool for sudden cardiac death risk stratification in patients who have or are scheduled to undergo ICDs, and 2) define whether delayed enhancement CT is comparable to the current non-invasive gold standard of CMR for identifying myocardial scar.
- Conditions
- Ventricular Arrhythmias
- Keywords
- Ischemic Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start4 Mar 2021
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Jonathan Chrispin, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394637
- Sponsor's protocol ID
- IRB00236647
- Status last verified
- Jun 2026
- First submitted
- 14 May 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra High Resolution CT to Assess Role of Intramyocardial Fat and Delayed Enhancement in Ventricular Arrhythmogenesis
- ClinicalTrials.gov ID
- NCT04394637
- Acronym / sponsor ID
- IRB00236647
- Conditions
- Ventricular Arrhythmias
- Keywords
- Ischemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The investigators aim to investigate the role of intramyocardial fat on ventricular arrhythmogenesis. Intramyocardial fat deposition has been frequently observed in patients with ischemic heart disease and is readily detectable by multi-detector computed tomography (MDCT) with high sensitivity and specificity, unlike other modalities. Like intramyocardial fat, reentrant ventricular tachycardia (VT) tends to occur late after the onset of myocardial infarction and the investigators hypothesize that lipomatous metaplasia within the infarct may precipitate later onset ventricular arrhythmias (VA). Prior studies have shown that intramyocardial fat correlates with slow myocardial conduction velocity and with critical circuits for VA but the investigators do not know the causal relationship between intramyocardial fat and future risk of VA.
Intramyocardial fat deposition or lipomatous metaplasia has been frequently observed in patients with ischemic heart disease and is readily detectable by multi-detector computed tomography (MDCT) with high sensitivity and specificity. Like intramyocardial fat, reentrant ventricular tachycardia (VT) tends to occur late after the onset of myocardial infarction and the investigators hypothesize that there may be a causal relationship. Prior studies have shown that intramyocardial fat correlates with slow myocardial conduction velocity and with critical circuits for VT in patients referred for VT ablation who already manifest VA.
However, the correlation of intramyocardial fat on CT with late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) in a general population of patients with ischemic cardiomyopathy with no prior history of VA has not been reported. Specifically, it is unknown whether the presence, distribution and/or volume of fat is an independent predictor of VA. Further CMR is less widely available in medical centers, and is more expensive with longer scanning times compared to CT. CT provides higher spatial resolution, is widely available and is not as susceptible to magnetic interference from internal cardiac defibrillator (ICD) generators and thus makes it an attractive imaging modality for risk stratification, particularly longitudinally over time.
Hypothesis: The investigators' 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, the investigators aim to assess the independent association of intramyocardial fat with VA and determine whether it adds any utility above LGE measured by CMR. Finally, the investigators will assess how well delayed enhanced CT correlates with LGE on MRI and test its association with ventricular arrhythmias.
Importance: The significance of the investigators' research is that the investigators will: 1) test whether intramyocardial fat on CT can be used as a non-invasive tool for sudden cardiac death risk stratification in patients who have or are scheduled to undergo ICDs, and 2) define whether delayed enhancement CT is comparable to the current non-invasive gold standard of CMR for identifying myocardial scar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of intramyocardial fat in patients with ischemic heart disease
Time frame: 2 years
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.
Prevalence of delayed enhanced CT detected scar
Time frame: 2 years
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.
Quantification of delayed enhanced CT detected scar
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Chrispin, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmias, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intramyocardial fat in patients with ischemic heart disease (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.