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

50 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{3 11 12 13 14}

Research Team

Armin A Zadeh, MD

Principal Investigator

Johns Hopkins University

Eligibility 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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Coronary angiography: a decade of advances. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Coronary CT angiography: Diagnostic value and clinical challenges. [2021]

3. Australia 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? [2016]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Technical and clinical aspects of coronary computed tomography angiography. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Correlation of radiation dose and heart rate in dual-source computed tomography coronary angiography. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

Declining radiation dose of coronary computed tomography angiography: German cardiac CT registry experience 2009-2014. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes following coronary computerized tomographic angiography for evaluation of emergency department patients with potential acute coronary syndrome. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Radiation dose at CT coronary angiography: how low can we go? [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. [2022]

12. Uganda pubmed.ncbi.nlm.nih.gov

The comparison of high and standard definition computed tomography techniques regarding coronary artery imaging. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluate of the effect of low tube voltage on the radiation dosage using 640-slice coronary CT angiography. [2019]

14. United States 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. [2022]