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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Coronary heart disease

Secondary outcome measures

Number of adverse outcomes

Number of coronary arteries with abnormal fractional flow reserve

Radiation Dose

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

N/A

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canon Medical Systems, USAIndustry Sponsor

9 Previous Clinical Trials

744 Total Patients Enrolled

1 Trials studying Coronary Artery Disease

140 Patients Enrolled for Coronary Artery Disease

Johns Hopkins UniversityLead Sponsor

2,267 Previous Clinical Trials

14,837,512 Total Patients Enrolled

27 Trials studying Coronary Artery Disease

56,529 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to geriatric individuals?

"This clinical study is looking for participants aged between 45 and 85 years old."

Answered by AI

Are there still spots available for enrollment in this experiment?

"According to clinicaltrials.gov, this medical research is presently recruiting individuals for participation. It was initially posted on November 22nd 2019 and most recently revised on July 5th 2022."

Answered by AI

How many participants have been recruited for this clinical examination?

"Yes, according to clinicaltrials.gov, this medical experiment is currently looking for volunteers; it was originally posted on November 22nd 2019 and most recently updated on July 5th 2022. 43 individuals are needed from one specified location."

Answered by AI

What criteria must potential participants meet to join this experiment?

"For this clinical trial, 43 individuals aged between 45 and 85 years with a prior diagnosis of coronary artery disease are being enrolled. Moreover, women of childbearing age must prove negative for pregnancy within 24 hours before the commencement of the study CTA. This is in order to guarantee that these criteria can be met: pre-existing documentation indicating at least 50% stenosis on an angiogram or evidence of revascularization through percutaneous coronary intervention (PCI)."

Answered by AI

Recent research and studies

American Journal of RoentgenologyJournal

Assessment of In-stent Restenosis Using 64-MDCT: Analysis of the CORE-64 Multicenter International Trial

Wykrzykowska, Joanna J., Armin Arbab-Zadeh, Gustavo Godoy, Julie M. Miller, Shezhang Lin, Andrea Vavere, Narinder Paul, et al.. 2010. “Assessment of In-stent Restenosis Using 64-MDCT: Analysis of the CORE-64 Multicenter International Trial”. American Journal of Roentgenology. American Roentgen Ray Society. doi:10.2214/ajr.09.2652.

European Journal of RadiologyJournal

Diagnostic Performance of Coronary CT Angiography with Ultra-high-resolution CT: Comparison with Invasive Coronary Angiography

Takagi, Hidenobu, Ryoichi Tanaka, Kyohei Nagata, Ryo Ninomiya, Kazumasa Arakita, Joanne D. Schuijf, and Kunihiro Yoshioka. 2018. “Diagnostic Performance of Coronary CT Angiography with Ultra-high-resolution CT: Comparison with Invasive Coronary Angiography”. European Journal of Radiology. Elsevier BV. doi:10.1016/j.ejrad.2018.01.030.

Journal of the American College of CardiologyJournal

Diagnostic Accuracy of Computed Tomography Coronary Angiography According to Pre-test Probability of Coronary Artery Disease and Severity of Coronary Arterial Calcification

Arbab-Zadeh, Armin, Julie M. Miller, Carlos E. Rochitte, Marc Dewey, Hiroyuki Niinuma, Ilan Gottlieb, Narinder Paul, et al.. 2012. “Diagnostic Accuracy of Computed Tomography Coronary Angiography According to Pre-test Probability of Coronary Artery Disease and Severity of Coronary Arterial Calcification”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2011.06.079.

European Heart JournalJournal