Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03263806
Status:
TERMINATED
Last Update Posted:
2018-07-03
First Post:
2017-08-24
Brief Title:
The Computed Tomography-derived Fractional Flow Reserve STAT Trial
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Computed Tomography-derived Fractional Flow Reserve in the Systematic Triage of Emergency Department Acute Chest Pain Patients to Treatment The CTFFR-STAT Trial
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTFFR-STAT
Brief Summary:
This study is designed to directly compare Standard Care and CT fractional flow reserve CTFFR for diagnosis of chest pain patients with definite coronary artery disease CAD on heart computed tomography CT scans
Detailed Description:
New or worsening chest discomfort is the most common symptom of coronary artery disease CAD which is plaque build-up in the arteries that supply the heart muscle with blood Chest pain is one of the most common reasons for emergency department ED visits with an estimated 8 million new cases every year Evaluation of chest pain is expensive and time consuming even though 75 of the time it is not due to CAD It is necessary to carefully define the amount of CAD even if initial tests reveal no heart attack because this symptom may progress to heart attack and death if missed
Coronary artery computed tomography angiography of the heart CCTA is one of the most sensitive tests to detect serious CAD in appropriately selected patientsIn 85 of acute chest pain ACP ED cases tested by CCTA no CAD or very mild CAD is found leading to rapid discharge or an alternative diagnosis However in the 15 of patients with significant CAD found on CCTA further evaluation with either stress testing or heart catheterization andor hospital admission is required Since 2015 Beaumont Health hospitals have employed a new FDA-approved test called CT fractional flow reserve CTFFR that can analyze flow down the heart arteries by computer analysis of the original CT images Results from an analysis of 147 patients suggest that 67 of the time CTFFR showed no significant flow limitation providing for the potential to defer invasive testing or treatment for a trial of medical therapy
The use of CTFFR on ED patients is novel and it is not yet part of the standard of care SOC Standard care of patients with definite CAD on CCTA continues to be hospital admission stress testing andor heart catheterization for further diagnosis Both CTFFR and standard care continue to be used at Beaumont Health and it is important to determine if one or the other diagnostic strategy is superior This study is designed to directly compare standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on CCTA
Coronary artery computed tomography angiography of the heart CCTA is one of the most sensitive tests to detect serious CAD in appropriately selected patientsIn 85 of acute chest pain ACP ED cases tested by CCTA no CAD or very mild CAD is found leading to rapid discharge or an alternative diagnosis However in the 15 of patients with significant CAD found on CCTA further evaluation with either stress testing or heart catheterization andor hospital admission is required Since 2015 Beaumont Health hospitals have employed a new FDA-approved test called CT fractional flow reserve CTFFR that can analyze flow down the heart arteries by computer analysis of the original CT images Results from an analysis of 147 patients suggest that 67 of the time CTFFR showed no significant flow limitation providing for the potential to defer invasive testing or treatment for a trial of medical therapy
The use of CTFFR on ED patients is novel and it is not yet part of the standard of care SOC Standard care of patients with definite CAD on CCTA continues to be hospital admission stress testing andor heart catheterization for further diagnosis Both CTFFR and standard care continue to be used at Beaumont Health and it is important to determine if one or the other diagnostic strategy is superior This study is designed to directly compare standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on CCTA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None