Evaluating new radiation techniques for heart imaging
Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography
NA · National Institutes of Health Clinical Center (CC) · NCT01621594
This study is testing new heart imaging techniques that use less radiation to see if they can still provide accurate results for diagnosing coronary disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01621594 on ClinicalTrials.gov |
What this trial studies
This study aims to assess new methods of computed tomography (CT) imaging that reduce radiation exposure while maintaining image accuracy for diagnosing coronary disease. Participants will undergo a CT scan of the heart and blood vessels, potentially using a contrast agent to enhance image quality. The study will involve screening participants through physical exams and medical history, along with blood tests to evaluate kidney function. The goal is to determine the effectiveness of these innovative imaging techniques in producing reliable results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a coronary CT angiography exam.
Not a fit: Patients who are pregnant or have severe renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer imaging techniques that minimize radiation exposure for patients undergoing heart evaluations.
How similar studies have performed: Other studies have explored radiation reduction techniques in imaging, showing promising results, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: 1. Clinical indication for a coronary CT angiography exam 2. Age equal to or greater than 18 years 3. Able to understand and willing to sign the Informed Consent Form 4. Able and willing to provide follow-up information EXCLUSION CRITERIA: 1. Pregnancy 2. 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. 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Marcus Y Chen, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Margaret C Lowery, R.N.
- Email: peg.lowery@nih.gov
- Phone: (301) 451-3128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Disease, computer tomography, Cardiac, Radiation Reduction, Iterative Reconstruction