High-Resolution CT vs. Angiography for Coronary Artery Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Allergy to contrast, Myeloma, Transplant, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Cardiac catheterization with invasive coronary angiography is the gold standard for determining the presence or absence of significant coronary heart disease (CHD). However, cardiac catheterization is costly and, as an invasive procedure, it is associated with some risk of adverse events, rarely even stroke, myocardial infarction, or death. Recent advances in multi-detector computed tomography angiography (CTA) have allowed rapid, noninvasive coronary artery imaging in patients with suspected CHD. CTA generally yields high accuracy for identifying patients with CHD when compared to cardiac catheterization. However, diagnostic accuracy is reduced in the setting of severe coronary artery calcification and coronary stents due to its inferior spatial resolution compared to cardiac catheterization. Because high-risk patients often have severe coronary calcification or stents, the application of CTA has been particularly limited in this important patient group. Recently, an ultrahigh-resolution CT scanner was released which has shown promise to overcome the limitation of conventional CTA in the setting of severe coronary artery calcification or stents. This ultrahigh-resolution "precision" CT scanner (UHR-CT) contains detector rows with half the width than currently available systems (0.25 mm vs. 0.5 mm) resulting in approximately twice the spatial resolution.
The purpose of this investigation is to test the hypothesis that high-resolution CTA is not inferior to the current standard of cardiac catheterization for identifying significant CHD in patients with high-risk characteristics, including severe coronary artery calcification and coronary stents.
The investigators propose to enroll 50 patients over 24-30 months in this investigation as part of a multicenter study. Patients referred for cardiac catheterization with known CHD and suspected obstructive coronary artery stenosis will be included. All patients will undergo both cardiac catheterization and UHR-CT for determining significant CHD as defined by coronary functional assessment. The primary end point will be the diagnostic accuracy by area-under-curve (AUC) method for identifying patients with hemodynamically significant CHD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment High-Resolution CT vs. Angiography for Coronary Artery Disease?
Coronary CT angiography is effective in diagnosing coronary artery disease, especially with newer technology like 64-slice and 320-slice CT scanners, which provide high-quality images and reliable results. It is particularly useful for patients at intermediate risk of coronary artery disease, offering detailed information about the type and amount of plaque in the arteries.
12345Is coronary CT angiography generally safe for humans?
Coronary CT angiography is considered safe when performed by trained professionals, with efforts to minimize radiation exposure. Studies show it is widely used and can be performed with low radiation doses, making it a reliable and safe option for evaluating coronary artery disease.
678910How does CT Angiography differ from other treatments for coronary artery disease?
CT Angiography (CTA) is a non-invasive test that uses advanced imaging technology to create detailed pictures of the coronary arteries, allowing doctors to see blockages or plaque without needing to insert a catheter into the heart. Unlike invasive coronary angiography, CTA can provide more information about the type and amount of plaque in the arteries and is particularly useful for patients at intermediate risk of coronary artery disease.
311121314Eligibility Criteria
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.Inclusion Criteria
I am suspected to have a blocked artery and may need a procedure to open it soon.
I have taken a pregnancy test in the last 24 hours and it was negative.
Ability to understand and willingness to sign the Informed Consent Form
+1 more
Exclusion Criteria
I have had heart surgery in the past.
My kidney function is reduced, with high creatinine or low clearance.
I have had multiple myeloma or an organ transplant.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Up to 8 weeks
1 visit (in-person)
Imaging
Participants undergo UHR-CT angiography and conventional coronary angiography
Less than 60 days
2 visits (in-person)
Follow-up
Participants are monitored for adverse events and diagnostic accuracy is assessed
30 days
1 visit (in-person)
Participant Groups
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.
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.
CT Angiography is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Computed Tomography Angiography for:
- Diagnosis of coronary artery disease
- Detection of coronary stenosis
🇺🇸 Approved in United States as Computed Tomography Angiography for:
- Diagnosis of coronary artery disease
- Detection of coronary stenosis
- Evaluation of cardiac structure and function
🇨🇦 Approved in Canada as Computed Tomography Angiography for:
- Diagnosis of coronary artery disease
- Detection of coronary stenosis
🇯🇵 Approved in Japan as Computed Tomography Angiography for:
- Diagnosis of coronary artery disease
- Detection of coronary stenosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins HospitalBaltimore, MD
Loading ...
Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
Canon Medical Systems, USAIndustry Sponsor
References
Coronary angiography: a decade of advances. [2019]Coronary angiography remains the definitive diagnostic technique for determining appropriate therapy of obstructive coronary artery disease, as well as for assessing the therapeutic results of surgery, angioplasty or thrombolytic therapy. Technologic improvements over the last 5 to 10 years have significantly enhanced both the diagnostic quality and the safety of coronary angiography. Among these improvements are the use of double-angulated vessel views, digital enhancement and postprocessing maneuvers and the use of low-osmolality contrast media. Newer noninvasive imaging techniques, such as cine-computered tomography, magnetic resonance imaging and digital echocardiography continue to play a very limited role in establishing the pathoanatomy of the coronary circulation.
Coronary CT angiography: Diagnostic value and clinical challenges. [2021]Coronary computed tomography (CT) angiography has been increasingly used in the diagnosis of coronary artery disease due to improved spatial and temporal resolution with high diagnostic value being reported when compared to invasive coronary angiography. Diagnostic performance of coronary CT angiography has been significantly improved with the technological developments in multislice CT scanners from the early generation of 4-slice CT to the latest 320- slice CT scanners. Despite the promising diagnostic value, coronary CT angiography is still limited in some areas, such as inferior temporal resolution, motion-related artifacts and high false positive results due to severe calcification. The aim of this review is to present an overview of the technical developments of multislice CT and diagnostic value of coronary CT angiography in coronary artery disease based on different generations of multislice CT scanners. Prognostic value of coronary CT angiography in coronary artery disease is also discussed, while limitations and challenges of coronary CT angiography are highlighted.
What is the role of invasive versus non-invasive coronary angiography in the investigation of patients suspected to have coronary heart disease? [2016]The improved technology of multi-slice cardiac CT angiography (CTA) has enabled production of high quality images of the coronary arteries. The sensitivity and specificity of the test in identifying patients with obstructive coronary lesions in 64-slice and later generations of scanners is high. To enable effective use of CTA in the clinical setting, a better understanding of this technology, particularly in comparison to invasive coronary angiography, is needed. In this article we discuss the characteristics of CTA in comparison to invasive coronary angiography and discuss the role of CTA in the diagnosis of coronary artery disease (CAD). Newer CTA scanners and individualized scanning protocols can minimize radiation exposure from CTA. CTA can provide more information than invasive coronary angiography on the type and burden of atherosclerotic plaque in the coronary tree. CTA is most useful in those at intermediate risk of CAD.
Prognostic value of coronary computed tomography (CT) angiography. [2021]Coronary computed tomography angiography (CTA) allows increasingly reliable visualization of the coronary arteries. Over the past two years, several relevant scientific studies on the clinical utility and prognostic value of CT angiography have been published, and this review will provide a summary of the currently available data.
Technical and clinical aspects of coronary computed tomography angiography. [2019]Coronary computed tomography angiography is an emerging imaging technique that has attracted much scientific attention over the past years. Improved scanner technology and dedicated protocols have made noninvasive coronary a reliable diagnostic test in patients with suspected coronary artery disease (CAD). Several technical steps such as the introduction of 64-slice scanners, multisegment reconstruction, and dual-source computed tomography have substantially improved temporal and spatial resolution. With these sophistications, coronary computed tomography angiography enables reliable exclusion of CAD in patients with low to intermediate pretest probability of having CAD or with inconsistent ischemia test results.
Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study. [2022]Since the safety of coronary CT angiography (CTA) is of great importance, especially with regard to widening indications and increasing morbidity, the aim of this study was to assess influencing factors.
Correlation of radiation dose and heart rate in dual-source computed tomography coronary angiography. [2016]Computed tomography coronary angiography (CTCA) has been widely used since the introduction of 64-slice scanners and dual-source CT technology, but the relatively high radiation dose remains a major concern.
Declining radiation dose of coronary computed tomography angiography: German cardiac CT registry experience 2009-2014. [2018]Coronary computed tomography angiography (CTA) is increasingly used as a test to rule out coronary artery disease (CAD) in patients with a low to intermediate pre-test probability of the disease. We used the database of the German CT registry, collected between 2009 and 2014 in a broad patient population, to analyze contemporary radiation dose associated with coronary CTA in clinical practice.
One-year outcomes following coronary computerized tomographic angiography for evaluation of emergency department patients with potential acute coronary syndrome. [2016]Coronary computerized tomographic angiography (CTA) has high correlation with cardiac catheterization and has been shown to be safe and cost-effective when used for rapid evaluation of low-risk chest pain patients from the emergency department (ED). The long-term outcome of patients discharged from the ED with negative coronary CTA has not been well studied.
Radiation dose at CT coronary angiography: how low can we go? [2016]Computed tomography (CT) coronary angiography is now a widely available and reliable test accessible on basic CT platforms that can exclude coronary heart disease with confidence. It is fast, cheap and, if properly carried out by trained and accredited staff in carefully selected patients, useful information can be obtained with acceptably low radiation exposure in some cases.
Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. [2022]To compare the image quality, evaluability, diagnostic accuracy, and radiation exposure of high-spatial-resolution (HR, 0.23-mm) computed tomographic (CT) coronary angiography with standard spatial resolution (SR, 0.625-mm) 64-section imaging in patients at high risk for coronary artery disease (CAD) by using invasive coronary angiography (ICA) as the reference method.
The comparison of high and standard definition computed tomography techniques regarding coronary artery imaging. [2018]The aim was to compare coronary high-definition CT (HDCT) with standard-definition CT (SDCT) angiography as to radiation dose, image quality and accuracy.
Evaluate of the effect of low tube voltage on the radiation dosage using 640-slice coronary CT angiography. [2019]640-slice coronary CT angiography is becoming an accurate and reliable method of diagnosing coronary heart disease. However, how to reduce the radiation dosage while ensuring the clinically acceptable image quality remains a quite challenging issue.
Influence of irregular heart rhythm on radiation exposure, image quality and diagnostic impact of cardiac computed tomography angiography in 4,339 patients. Data from the German Cardiac Computed Tomography Registry. [2022]Coronary computed tomography angiography (coronary CTA) provides non-invasive evaluation of the coronary arteries with high precision for the detection of significant coronary artery disease (CAD).