Heart study: which imaging test leads to better outcomes?
NCT ID NCT07308496
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two imaging methods—CT-FFR and QFR—to see which better guides treatment decisions for people with coronary artery disease. About 1,400 participants with moderate blockages will be randomly assigned to one of the two approaches. The goal is to find out which method reduces the risk of major heart problems like heart attack or death within one year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 1,402 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patient-level inclusion criteria: 1. Adults aged ≥18 years. 2. Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours. 3. Patients are able and willing to provide written informed consent. Lesion-level inclusion criteria: (1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm. Patient-level exclusion criteria: 1. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 2. Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase). 3. Moderate to severe chronic kidney disease, defined as serum creatinine \>150 μmol/L or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². 4. Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery. 5. Atrial fibrillation or other severe cardiac arrhythmias. 6. Refusal or inability to sign informed consent. Lesion-level exclusion criteria: 1. Poor-quality CCTA images that prevent CT-FFR analysis. 2. Severe coronary vessel tortuosity, overlapping segments, or other factors expected to cause poor-quality invasive angiography, hindering QFR measurement. 3. Combined with chronic total occlusion lesions. 4. The stenosis degree of the left main coronary artery was ≥50%.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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