NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging
| NCT ID | NCT01621594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Coronary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2012-06-21 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2012-06-21 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Marcus Y Chen, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT01621594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01621594 currently recruiting?
Yes, NCT01621594 is actively recruiting participants. Contact the research team at peg.lowery@nih.gov for enrollment information.
Where is the NCT01621594 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01621594 clinical trial?
NCT01621594 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Marcus Y Chen, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 5,000 participants.