An interventional study of Cannon Aquilion ONE CT system in Coronary Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Diagnostic
Among 194 studies in Coronary Disease by National Heart, Lung, and Blood Institute (NHLBI) — 2 open to participants now, 6 under way, none of them phase 3. Coronary Disease · National Heart, Lung, and Blood Institute (NHLBI).
Among the 194 studies in Coronary Disease by National Heart, Lung, and Blood Institute (NHLBI), this one is the 2nd largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2012, is one of 3 with no phase, and was the 192nd registered.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
Browse Coronary Disease studies →2 of the 194 studies in Coronary Disease by National Heart, Lung, and Blood Institute (NHLBI) are open now, in 1 country. Recruiting first, the newest first:
National Heart, Lung, and Blood Institute (NHLBI) · Sites in United States
By country, each count listing its studies:
Of the 106 Coronary Disease studies recruiting now, 64 (60%) set no upper age limit and 19 (18%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
194 studies; the count open now beside each. This study's row is marked.
First in 1948; this study’s year is marked. 1 started in 2012.
This study's planned enrollment of 5,000 is above the median of 160 across 778 interventional studies indexed under Coronary Disease.
Median enrollment 200 across the 11 interventional studies, 5,000 across the 13 observational. Of the 188 that completed or were terminated, 1 (1%) have results posted.
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National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.
1 of the studies in Coronary Disease by National Heart, Lung, and Blood Institute (NHLBI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01621594National Heart, Lung, and Blood Institute (NHLBI)Evaluating New Radiation Techniques for Cardiovascular Imaging | 2027-04-01 |
Among the 194 studies in Coronary Disease by National Heart, Lung, and Blood Institute (NHLBI), from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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 Artificial Intelligence (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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical indication for a coronary CT angiography exam
EXCLUSION CRITERIA:
Screen Failures: Subjects who are screen failures can be re-enrolled once they meet eligibility criteria. Rescreened participants will be assigned the same participant number as for the initial screening.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with Clinical indication for a coronary CT angiography exam
Device: Cannon Aquilion ONE CT system
To test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.
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.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Compare and/or validate radiation saving techniques such as iterative reconstruction or artificial intelligence based methods against standard imaging techniques for calcium scoring.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Evaluate natural history of coronary plaques in subjects with serial imaging if requested by ordering physician, or in subjects with >50% stenosis or high risk plaques on medical therapy.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Estimate diagnostic accuracy of cardiovascular evaluations using current CT technology vs. invasive angiography reports/images and vs. stress perfusion MRI reports/images.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Evaluate image quality from new CT technology.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Estimate radiation dose from clinically performed cardiovascular CT at the NIH compared to outside clinically indicated CTs.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time frame: ongoing
Plan to share: Undecided
Started Jun 2012 (actual). Primary completion is estimated for Apr 2027, 177 months after the start.
Of 178 non-industry interventional studies with no phase under Coronary Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 177 months is above that.
Counting every sponsor, half of 200 studies reached it within 25 months; a quarter within 14 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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