CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve

ConditionPatient Preference

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age20+

SponsorFujita Health University

About this trial

Fractional flow reserve (FFR)-guided PCI for chronic coronary syndromes (CCS) is reported to improve the outcomes compared with angiography-guided PCI. However, cardiac-events still occur in FFR-deferral patients in long-term follow-up. Coronary computed tomography angiography (CTA)-defined high-risk-plaque (HRP) is known to relate future cardiac events. The investigators hypothesized that CTA might identify plaque features linked to future cardiac events in deferral patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

men and women aged ≥20 years,

patients having chronic coronary syndromes (CCS,

Coronary computed tomography angiography (CTA) was performed within 90 days before invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement.

Disqualifiers

patients with a history of coronary bypass grafting (CABG) because CABG changed local coronary flow dynamics,

patients with left-main disease,

patients with fractional flow reserve (FFR) in stented vessels due to inability to estimate plaque morphology in the stented lesion by coronary computed tomography angiography.

Trial population

A consecutive series of 437 patients who underwent CTA within 90 days before ICA with FFR pressure measurement were candidates for this study at Fujita Health University Hospital, Bantane Hospital, and Nagoya First Red Cross Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement
Diagnostic test
A consecutive series of patients who underwent Coronary computed tomography angiography (CTA) within 90 days before invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement were candidates for this study at Fujita Health University Hospital, Bantane Hospital, and Nagoya First Red Cross Hospital

Treatment groups

400 Participants

are divided into 1 treatment group

Group A: Patients who underwent CTA within 90 days before ICA with FFR pressure1 intervention

Trial outcomes

Primary outcomes

Cardiac events in patient level

a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-level analysis

Time frame

From 2018 to 2026

Cardiac events in lesion level

lesion-level ACS and lesion-level ischemia-driven revascularization

Time frame

From 2018 to 2026

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujita Health University

Lead sponsor

Source ClinicalTrials.gov

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