Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03901326
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2019-03-30
Brief Title:
Role of On-site CT-derived FFR in the Management of Suspect CAD Patients
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
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
Status Verified Date:
2023-12
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARGET
Brief Summary:
The primary of this registry is to evaluate whether the availability of CTACT-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 CTACT-FFR care group CTACT-FFR arm via computer-generated random numbers 11 ratio
Detailed 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 trial1-3 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 CTACT-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None