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Clinical Trial Summary

This study is multicenter, randomized controlled design to further evaluate whether the CT-FFR procedure could effectively optimize the flow of clinical practice of CAD diagnosis, avoid the overuse of invasive procedure, finally improving clinical prognosis and reducing total medical expenditure.

Clinical Trial Description

Based on the clinical practice during which less stress SPECT and stress MRI are performed other than stress ECG in China, more patients undergo cardiac CT tests for determining whether they should be sent to Cath lab. However, nearly 30% of patients sent to Cath lab were unnecessary. One the other hand, CT-FFR technology showed a great potential in detecting functional myocardial ischemia related to epicardial coronary artery (Discovery-Flow, DEFACTO and NXT trial). Moreover, CT-FFR guided care could result in equivalent clinical outcomes and lower expenditure, compared with usual care over 1-year follow-up (Platform trial). ADVANCE study revealed that´╝îin real-world international multicentre population, CT-FFR modified treatment recommendation was associated with less negative ICA, predicted revascularization, and identified subjects at low risk of adverse events through 90 days. However, these studies was not randomized designed, and selection bias still existed. So, our study is aim to evaluate that whether CT/CT-FFR outperform the regular diagnostic care in ruling out patients without significantly hemodynamic obstructive CAD before catheter lab and improving clinical prognosis during follow up in a randomized design. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03901326
Study type Interventional
Source Chinese PLA General Hospital
Contact Junjie Yang, MD
Phone 86-13581662680
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date December 2021

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