Status:
COMPLETED
Ultra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Canon Medical Systems, USA
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
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...
Detailed Description
1\. Objectives:Primary Objective The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is not inferior to invasive coronary angiograp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04272060
Start Date
November 22 2019
End Date
July 31 2025
Last Update
August 11 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287