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Advanced CT Imaging Techniques for Coronary Heart Disease

N/A
Recruiting
Led By Marcus Y Chen, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical indication for a coronary CT angiography exam
Age equal to or greater than 18 years
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying new ways of taking pictures of the heart or blood vessels using computed tomography to see how effective they are in producing accurate CT scans.

Who is the study for?
This trial is for adults over 18 who need a coronary CT angiography exam to check their heart or blood vessels. They must understand and sign consent, be able to follow up, and have working kidneys if using contrast. Pregnant individuals or those with severe kidney issues can't join.
What is being tested?
Researchers are testing new low-radiation techniques in the Toshiba Aquilion ONE CT system for imaging the heart and blood vessels. Participants will undergo a detailed scan session that could use a contrast agent and will be followed up after 90 days, then yearly for five years.
What are the potential side effects?
Potential side effects may include reactions to the contrast agent used during scanning (if applicable), such as allergic reactions or kidney function impairment. The reduced radiation technique aims to minimize exposure-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need a heart scan to check my arteries.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe kidney issues with a low filtration rate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
new imaging methods are accurate or predict subject outcomes.
Secondary study objectives
Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI.
Estimate radiation dose from clinically performed cardiovascular CT.
Evaluate image quality from new CT technology.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Subjects with Clinical indication for a coronary CT angiography exam

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,944 Previous Clinical Trials
47,794,832 Total Patients Enrolled
Marcus Y Chen, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
6 Previous Clinical Trials
6,412 Total Patients Enrolled

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT01621594 — N/A
Coronary Heart Disease Research Study Groups: 1
Coronary Heart Disease Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT01621594 — N/A
1 2023 Treatment Timeline for Medical Study. Trial Name: NCT01621594 — N/A
~763 spots leftby Apr 2027
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