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Imaging

High-Resolution CT vs. Angiography for Coronary Artery Disease

N/A
Recruiting
Led By Armin A Zadeh, MD PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA
Patients aged 45-85 years with history of CHD defined as prior documentation of a coronary artery stenosis of 50% or greater by coronary angiography or by prior documentation of coronary artery revascularization by percutaneous coronary intervention (PCI)
Must not have
Previous coronary artery bypass or other cardiac surgery
Elevated serum creatinine (> 1.5mg/dl) or calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a new, high-resolution CT scanner is not inferior to cardiac catheterization for identifying significant CHD in patients with high-risk characteristics, including severe coronary artery calcification and coronary stents.

Who is the study for?
This trial is for adults aged 45-85 with a history of coronary heart disease (CHD), specifically those who have had a stenosis or revascularization, and are suspected to have obstructive coronary artery stenosis. It's not suitable for individuals with certain heart conditions, allergies to iodine contrast media, kidney issues, or uncontrolled heart rhythm problems.
What is being tested?
The study compares ultra-high-resolution CT angiography (UHR-CT) against the standard invasive coronary angiography in detecting significant CHD. Participants will undergo both procedures so researchers can assess if UHR-CT is as accurate as the current gold standard.
What are the potential side effects?
Invasive coronary angiography may lead to rare but serious side effects like stroke, myocardial infarction, or death. CT angiography generally has fewer risks but can still cause reactions to contrast media used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have taken a pregnancy test in the last 24 hours and it was negative.
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I am between 45-85 years old and have a history of heart disease with significant artery narrowing or have had a procedure to open my heart's arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had heart surgery in the past.
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My kidney function is reduced, with high creatinine or low clearance.
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I have had multiple myeloma or an organ transplant.
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I have severe heart failure symptoms.
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I have an irregular heartbeat or a severe heart block.
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I have been diagnosed with moderate or severe narrowing of my heart's aortic valve.
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I am suspected to have a heart condition related to blocked arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Coronary heart disease
Secondary study objectives
Number of adverse outcomes
Number of coronary arteries with abnormal fractional flow reserve
Radiation Dose

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CT AngiographyExperimental Treatment1 Intervention
Research CT angiography.
Group II: Conventional AngiographyActive Control1 Intervention
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CT angiography
2016
Completed Early Phase 1
~60

Find a Location

Who is running the clinical trial?

Canon Medical Systems, USAIndustry Sponsor
13 Previous Clinical Trials
1,234 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
140 Patients Enrolled for Coronary Artery Disease
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,760 Total Patients Enrolled
27 Trials studying Coronary Artery Disease
56,488 Patients Enrolled for Coronary Artery Disease
Armin A Zadeh, MD PhDPrincipal InvestigatorJohns Hopkins University

Media Library

CT Angiography (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT04272060 — N/A
Coronary Artery Disease Research Study Groups: Conventional Angiography, CT Angiography
Coronary Artery Disease Clinical Trial 2023: CT Angiography Highlights & Side Effects. Trial Name: NCT04272060 — N/A
CT Angiography (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04272060 — N/A
~5 spots leftby Jun 2025
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