Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06170541

Conditions

Coronary Heart Disease (CHD)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Aquilion Precision

Conventional Computed Tomography

Study Details

Brief summary:

The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans.

The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD.

Conditions

Coronary Heart Disease (CHD)

Study ID

NCT06170541

Start date

Apr 5, 2021

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients aged 21-85 years
  • Clinical history suggestive of CHD who are referred by their primary cardiologist for further evaluation via Computed tomography angiography (CTA) will be asked to participate.
  • Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
  • 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
  • History of prior percutaneous coronary intervention (PCI) in one or more vessel or history of coronary arterial bypass grafting (CABG)
  • Suspected acute coronary syndrome
  • Presence of any other history or condition that the investigator feels would be problematic

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision)

Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality.

active comparator: CR-CT (Conventional Resolution Computed Tomography)

Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality.

Interventions

Aquilion Precision

Ultra-High Resolution CT (UHR CT) capable of resolving anatomy as small as 150 microns, providing CT image quality with resolution typically seen only in cath labs. The UHR detector is newly designed to provide more than twice the resolution when compared with today's CT technology, with an all-new detector as well as tube, gantry and reconstruction technologies.

Conventional Computed Tomography

Conventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging.

Primary outcome measure

  • agreement between the number of patients with >70% stenosis detected by ultra-high-resolution tomography compared to conventional tomography, with catheterization considered as the gold standard. [ Time Frame: Up to 24 Months ]

Central Contacts and Locations

Central contacts

Joao Lima, Professor

4106141284jlima@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Michelle lHughes-Lukoski

mhughe17@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-13.