High-Resolution CT vs. Angiography for Coronary Artery Disease

Overseen By Aysa Ostovaneh, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Allergy to contrast, Myeloma, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new high-resolution CT scanner to determine if it matches the accuracy of the standard invasive procedure for detecting significant coronary heart disease (CHD). The goal is to assess whether this new CT scanner, known as CT Angiography, can effectively identify CHD in individuals with severe artery calcification or stents. Participants will undergo both a CT scan and the usual catheter-based angiography, known as Invasive Coronary Angiography. The trial seeks participants with known CHD who are suspected of having significant artery blockage, especially those with a history of artery procedures or tests indicating a blockage. As an unphased trial, it offers participants the chance to contribute to the advancement of non-invasive diagnostic methods for coronary heart disease.

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 prior data suggests that this ultrahigh-resolution CT scanner is safe for coronary artery imaging?

Research shows that CT angiography, a special heart scan, is generally safe and easy for patients to handle. Studies have found it has fewer complications than invasive coronary angiography, which involves inserting a tube into the heart. Because CT angiography is non-invasive, it avoids risks like bleeding or infection that can occur with instrument insertion.

Additionally, serious heart-related problems, such as heart attacks or strokes, are rare with CT angiography. Large studies have reported these serious events in only a small number of cases. This indicates that CT angiography offers a safer way to diagnose heart disease without the risks of more invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CT angiography for coronary artery disease because it offers a non-invasive alternative to the traditional invasive coronary angiography. Unlike standard procedures that require cardiac catheterization, CT angiography uses advanced imaging technology to visualize blood vessels, potentially reducing the risk and discomfort associated with invasive techniques. This method could make diagnosing coronary artery disease safer and more accessible for patients, providing quicker results without the need for hospitalization or recovery time.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that coronary computed tomography angiography (CTA), a method used in this trial, effectively detects coronary artery disease (CAD), even with stable chest pain. Studies have found that CTA accurately diagnoses and rules out blocked arteries, offering a reliable noninvasive alternative to traditional invasive methods. Participants in this trial will join either the CTA group or the Conventional Angiography group. CTA typically results in fewer complications, is faster, and costs less than invasive procedures. The new ultrahigh-resolution CT scanner aims to enhance CTA accuracy, particularly for patients with severe artery calcification or stents, and seeks to match the effectiveness of invasive tests. Overall, evidence supports that CTA accurately detects significant heart disease while reducing patient risk and discomfort. ^{3 5 6 7 8}

Who Is on the Research Team?

Armin A Zadeh, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• CT Angiography
• Invasive Coronary Angiography

Trial Overview 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.

How Is the Trial Designed?

Group I: CT Angiography Experimental Treatment 1 Intervention

Research CT angiography.

Group II: Conventional Angiography Active Control 1 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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Canon Medical Systems, USA

Industry Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

Coronary computed tomography angiography (CCTA) has become a reliable noninvasive diagnostic tool for detecting coronary artery disease (CAD), especially in patients with low to intermediate risk.

Advancements in scanner technology, such as 64-slice scanners and dual-source computed tomography, have significantly enhanced the accuracy and resolution of CCTA, allowing for effective exclusion of CAD in patients with uncertain ischemia test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical and clinical aspects of coronary computed tomography angiography. Schnapauff, D., Zimmermann, E., Dewey, M.[2019]

Multi-slice cardiac CT angiography (CTA) offers high sensitivity and specificity for detecting obstructive coronary lesions, making it a valuable non-invasive tool for diagnosing coronary artery disease (CAD).

CTA provides additional insights into the type and extent of atherosclerotic plaque compared to invasive coronary angiography, and it is particularly beneficial for patients at intermediate risk of CAD, while newer scanning protocols help reduce radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the role of invasive versus non-invasive coronary angiography in the investigation of patients suspected to have coronary heart disease? Chow, CK., Sheth, T.[2016]

High-spatial-resolution (HR) coronary CT angiography significantly improved image quality and evaluability compared to standard resolution (SR) CT angiography in 184 high-risk patients for coronary artery disease, with scores of 3.7 vs 3.4 and evaluability rates of 97% vs 92%.

HR coronary CT angiography demonstrated superior diagnostic accuracy for calcified plaques, with higher specificity and positive predictive values compared to SR CT angiography, indicating its potential as a more effective imaging tool for patients at high risk for coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. Pontone, G., Bertella, E., Mushtaq, S., et al.[2022]

Coronary computed tomography angiography (CTA) has become a more reliable method for visualizing coronary arteries, enhancing its clinical utility.

Recent studies over the past two years have demonstrated the prognostic value of CTA, indicating its importance in assessing heart health and predicting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of coronary computed tomography (CT) angiography. Achenbach, S.[2021]

In a study of 5500 patients undergoing coronary CT angiography (CTA), adverse events were rare (1.2%), with most being mild reactions, indicating that the procedure is generally safe, especially when performed in an outpatient setting.

Administering lower doses of glyceryl trinitrate (GTN) significantly reduced the occurrence of significant blood pressure drops during the procedure, particularly in older male patients with higher plaque burden, enhancing the overall safety of coronary CTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study. Andre, F., Fortner, P., Emami, M., et al.[2022]

High-definition CT (HDCT) provides better measurement accuracy and higher vessel attenuation values compared to standard-definition CT (SDCT), making it more effective for imaging coronary arteries, despite a higher radiation dose.

Both HDCT and SDCT showed similar image quality, but HDCT had a higher mean tube current (180 mA vs. 147 mA), indicating a trade-off between improved accuracy and increased radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of high and standard definition computed tomography techniques regarding coronary artery imaging. Aykut, A., Bumin, D., Omer, Y., et al.[2018]

A study of 5001 patients undergoing coronary computed tomography angiography (CTA) showed a significant decline in radiation dose over time, from an average of 5.6 mSv to 2.5 mSv, indicating improved safety in the procedure.

The reduction in radiation exposure is attributed to advancements in technology and protocols, including an increase in prospectively ECG-triggered examinations, which enhance the efficacy of coronary CTA while minimizing risks to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Declining radiation dose of coronary computed tomography angiography: German cardiac CT registry experience 2009-2014. Schmermund, A., Marwan, M., Hausleiter, J., et al.[2018]

CT coronary angiography is a reliable and efficient method for excluding coronary heart disease, providing quick results at a low cost.

When performed by trained professionals on selected patients, this test offers valuable insights with minimal radiation exposure, making it a safe option for assessing heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dose at CT coronary angiography: how low can we go? Eason, D., Leslie, SJ., Hince, AJ., et al.[2016]

Coronary angiography is the most reliable method for diagnosing obstructive coronary artery disease and evaluating the effectiveness of treatments like surgery and angioplasty, supported by advancements in technology over the past 5 to 10 years that have improved both safety and diagnostic quality.

Despite the emergence of newer noninvasive imaging techniques such as CT, MRI, and digital echocardiography, they have not significantly impacted the assessment of coronary circulation compared to traditional angiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary angiography: a decade of advances. Higgins, CB.[2019]

Using a 100 kV tube voltage setting in 640-slice coronary CT angiography significantly reduces the effective radiation dose by up to 67% compared to the 120 kV setting, while maintaining acceptable image quality.

The study involved 400 patients with coronary heart disease and demonstrated that lower tube voltage (100 kV) not only decreases radiation exposure but also improves the CT values of coronary arteries, indicating better image quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluate of the effect of low tube voltage on the radiation dosage using 640-slice coronary CT angiography. Liu, S., Fu, Q., Yu, H., et al.[2019]

Coronary CT angiography has shown significant improvements in diagnostic performance for coronary artery disease, especially with advancements from 4-slice to 320-slice CT scanners, offering high spatial and temporal resolution.

Despite its advantages, coronary CT angiography faces challenges such as inferior temporal resolution, motion artifacts, and a tendency for high false positive rates in cases of severe calcification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary CT angiography: Diagnostic value and clinical challenges. Sabarudin, A., Sun, Z.[2021]

In a study of 4,339 patients undergoing coronary CTA, 6% had irregular heart rhythms, which led to significantly higher radiation and contrast media exposure compared to those with stable sinus rhythm (6.2 mSv vs. 3.3 mSv and 90 mL vs. 80 mL, respectively).

Patients with irregular heart rhythms had a lower rate of successful exclusion of significant coronary artery disease (32.9% vs. 44.8%) and more non-diagnostic segments, but this did not result in increased follow-up stress testing or invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Korosoglou, G., Marwan, M., Giusca, S., et al.[2022]

In a study of 218 patients undergoing computed tomography coronary angiography (CTCA) with dual-source scanners, it was found that higher mean heart rates (above 65 bpm) were associated with increased radiation exposure, highlighting the importance of heart rate management during the procedure.

The research indicates that maintaining a mean heart rate below 65 bpm and minimizing fluctuations greater than 20 bpm can help reduce radiation doses, suggesting that careful monitoring of heart rate is crucial for patient safety during CTCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of radiation dose and heart rate in dual-source computed tomography coronary angiography. Laspas, F., Tsantioti, D., Roussakis, A., et al.[2016]

In a study of 481 low- to intermediate-risk patients evaluated in the emergency department with coronary CTA, there was only one death (0.2%) and no cases of nonfatal acute myocardial infarction (AMI) over a one-year follow-up, indicating a very low risk of serious cardiovascular events for those with negative results.

The findings suggest that coronary CTA is a safe and effective tool for ruling out acute coronary syndrome in low-risk patients, as those with negative results are unlikely to experience significant cardiovascular issues in the following year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes following coronary computerized tomographic angiography for evaluation of emergency department patients with potential acute coronary syndrome. Hollander, JE., Chang, AM., Shofer, FS., et al.[2016]

Citations

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Past, Present, and Future of CCTA | Circulation Studies like DISCHARGE and CONSERVE demonstrated similar outcomes between CCTA and invasive angiography, with lower procedural complications and ...

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Coronary CT Angiography - StatPearls - NCBI Bookshelf - NIH Coronary computed tomography angiography (CCTA) is a crucial CAD assessment diagnostic modality. This non-invasive approach proves invaluable for patients

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Computed Tomography vs Invasive Coronary Angiography ... The diagnostic yield of coronary angiography, defined as the proportion of invasive coronary angiographic studies showing obstructive CAD, was 73.7% in the ...

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Coronary CT angiography instead of invasive ... The study investigates feasibility and outcomes following a diagnostic workup of obstructive coronary artery disease in TAVI-candidates with combined Cardiac ...