Ultra High Resolution CT to Assess Role of Intramyocardial Fat and Delayed Enhancement in Ventric… (NCT04394637) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ultra High Resolution CT to Assess Role of Intramyocardial Fat and Delayed Enhancement in Ventricular Arrhythmogenesis
United States110 participantsStarted 2021-03-04
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of intramyocardial fat in patients with ischemic heart disease
Timeframe: 2 years
2
Prevalence of delayed enhanced CT detected scar
Timeframe: 2 years
3
Quantification of delayed enhanced CT detected scar