Ultra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease

Launched by JOHNS HOPKINS UNIVERSITY · Feb 13, 2020

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ClinConnect Summary

This clinical trial is studying a new type of imaging called ultrahigh-resolution computed tomography (UHR-CT) to see if it can effectively detect significant coronary heart disease (CHD) in patients who are at high risk. The current standard for diagnosing CHD is a procedure called cardiac catheterization, which is invasive and carries some risks. This trial aims to find out if UHR-CT, which is a non-invasive imaging method, can accurately identify CHD in patients with severe coronary artery calcification or stents, conditions that can make traditional imaging less effective.

To participate in this study, you should be between 45 and 85 years old and have a history of CHD, which means you’ve had significant narrowing of the coronary arteries in the past. You also need to be referred for cardiac catheterization because of suspected blockages. If you join the trial, you will undergo both the UHR-CT and the standard cardiac catheterization to compare how well each method works in detecting CHD. The study is currently recruiting participants and will take place over the next 2 to 2.5 years. It’s important to note that some patients may not be eligible, particularly those with certain pre-existing conditions or allergies. If you’re interested in learning more or think you might qualify, please talk to your doctor for more information.

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Eligibility criteria

• Inclusion Criteria:
• • Patients aged 45-85 years with history of CHD will be asked to participate. History of CHD is 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). Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
• • Suspected obstructive coronary artery stenosis based on clinical history and/or noninvasive testing, prompting a clinical referral for invasive coronary angiography; and/or planned PCI within the next 60 days.
• • Ability to understand and willingness to sign the Informed Consent Form.
• Exclusion Criteria:
• • Known allergy to iodinated contrast media
• • History of multiple myeloma or previous organ transplantation
• • Elevated serum creatinine (\> 1.5mg/dl) or calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula
• • Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third-degree heart block)
• • Evidence of severe symptomatic heart failure (NYHA Class III or IV);
• • Known or suspected moderate or severe aortic stenosis
• • Previous coronary artery bypass or other cardiac surgery
• • Patients without a history of CHD who had no or only mild coronary calcification on chest CT imaging within the past 5 years or had most recent coronary calcium scan with a score \<400
• • Suspected acute coronary syndrome
• • Presence of any other history or condition that the investigator feels would be problematic