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New CT scanner aims to replace invasive heart tests for High-Risk patients

NCT ID NCT04272060

Diagnosis Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new ultra-high-resolution CT scanner (UHR-CT) to the standard invasive coronary angiography for detecting significant blockages in the heart's arteries. It focuses on patients with severe calcium buildup or stents, where regular CT scans often fall short. The goal is to see if the UHR-CT can accurately identify which patients need further treatment without the risks of an invasive procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ultra-high-resolution CT scanner
What this could lead to
If successful, this could offer a noninvasive alternative to cardiac catheterization for diagnosing coronary artery disease in patients with severe calcification or stents.
What could go wrong
This is a small, early-phase study with only 50 patients, so results may not apply broadly. The CT may still miss some blockages compared to the invasive gold standard.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

175 people

The number who actually took part.

Started

Nov 2019

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • Hospital Israelita Albert Einstein

    São Paulo, Brazil

  • Iwate Medical University

    Morioka, Japan

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

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