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Active, not recruiting Not applicable

Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis

NCT03976921 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2019-07-01
Last updated
2026-06-03

Condition(s) studied

Coronary Artery DiseaseMyocardial Ischemia

Investigational drug(s) / intervention(s)

Integration of CCTA with stress CTP when indicatedStandard of care approach

Integration of CCTA with stress CTP when indicated: When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.

Standard of care approach: (a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.

Study summary

CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined. The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation. * CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan). Exclusion Criteria: * Performance of any non-invasive diagnostic testing within 90 days before enrollment * Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score * Acute coronary syndrome * Need for an emergent procedure * Evidence of clinical instability * Contra-indication to contrast agent administration and/or impaired renal function * Inability to sustain a breath hold * Pregnancy * Cardiac arrhythmias * Presence of pace maker or implantable cardioverter defibrillator * Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine * Structural cardiomyopathy outside of suspected or know ischemic heart disease

Primary outcome measure(s)

  • Reclassification rate of CCTA in group B due to the addition of CTP — 30 days.
    For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).

Trial sites (1)

FacilityCityRegionStatus
Centro Cardiologico Monzino IRCCS Milan MI
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03976921 on ClinicalTrials.gov ↗ ← All trials in Italy