Role of On-site CT-derived FFR in the Management of Suspect CAD Patients — TARGET  

Coronary Artery Disease Clinical Trial

Official title: The Effect of On-site CT-derived Fractional Flow Reserve on the Management Making for the Patients With Stable Chest Pain (TARGET Trial)

Status Completed

Clinical Trial Summary

The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)

Clinical Trial Description

Based on the clinical fact that less stress myocardial perfusion scan are performed rather than stress exercise electrocardiogram (ECG) in China, more patients undergo coronary computed tomographic angiography (CTA) for determining whether they should be sent to catheter lab. However, nearly 30% of patients sent to catheter lab were found without obstructive coronary artery disease (CAD) and this invasive procedure was unnecessary and overused partly. Fortunately, fractional flow reserve (FFR) based non-invasive CT algorithm technology (CT-FFR) showed a great potential in detecting functional myocardial ischemia related to coronary specific lesion (Discovery-Flow, DEFACTO and NXT trial)[1-3]. Moreover, clinical care guided by CT-FFR could provide benefits with equivalent clinical outcomes and lower expenditure, compared with routine clinical care over 1-year follow-up (Platform trial). On the other aspect, ADVANCE trial revealed that CT-FFR modified treatment recommendation was associated with less negative invasive coronary angiography (ICA), predicted revascularization and identified subjects at low risk of adverse events through 90 days in real-world. However, these studies was not randomized designed and selection bias still existed. So our trial aims to evaluate whether CTA/CT-FFR outperforms the regular diagnostic care in ruling out patients without significantly obstructive CAD before catheter lab and improving clinical prognosis during follow-up in a randomized design. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT03901326
• Study type: Interventional
• Source: Chinese PLA General Hospital
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Completion date: October 31, 2022