Evaluating New Radiation Techniques for Cardiovascular Imaging (NCT01621594) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating New Radiation Techniques for Cardiovascular Imaging
United States5,000 participantsStarted 2012-06-21
Plain-language summary
Title: Evaluating New Radiation Techniques for Cardiovascular Imaging
Background:
Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes.
Cardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease.
Cardiac imaging software and AI are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images.
Objectives:
\- To study new ways of taking pictures of the heart or blood vessels using computed tomography.
Eligibility:
\- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems.
Design:
* Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function.
* Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours.
* Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.
Who can participate
Age range
18 Years – 100 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
. Clinical indication for a coronary CT angiography exam
. Age equal to or greater than 18 years
. Able to understand and willing to sign the Informed Consent Form
. Able and willing to provide follow-up information
Exclusion criteria
. Pregnancy
. If receiving intravenous contrast, severe renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria or as reported by the clinical lab. Glomerular filtration rate will be estimated using the 2021 CK-EPI equation that eliminate the use of race coefficient as reported in CRIS.
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.
1This trial is comparing outcomes in people with different levels of coronary artery narrowing — based on my own imaging results, does my degree of coronary stenosis make me a relevant candidate to discuss this study with you?
2Since this trial is tracking serious events like heart attack, stroke, hospitalization, and death over time, what does that kind of long-term follow-up actually involve for me practically, and how would it fit into my regular care routine?
3The trial is listed as Phase NA, which suggests it may be more of an observational or imaging study rather than a treatment trial — can you explain whether I would be receiving any new treatment, or just being monitored and imaged differently than usual?
4Given that this study is measuring cardiovascular events in people with varying levels of coronary stenosis, would participating change how aggressively you manage my condition, or would I still receive the same standard treatment regardless?
5Are there any risks specific to the new radiation or imaging techniques being evaluated in this study that I should weigh against the potential benefit of being more closely monitored for cardiovascular events?
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
Compare time-to-first cardiovascular events (death, revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with >=50% coronary stenosis vs. <50% stenosis.
Timeframe: ongoing
Trial details
NCT IDNCT01621594
SponsorNational Heart, Lung, and Blood Institute (NHLBI)